Medical and drug safety

A leading biologics manufacturer is seeking an experienced manufacturing leader to oversee a critical drug substance manufacturing operation. This is a full-time, on-site position at a European manufacturing facility, offering the opportunity to lead high-performing teams, drive operational excellence, and support continued organisational growth. Comprehensive relocation assistance will be provided for candidates relocating from elsewhere in Europe or internationally. Key Responsibilities Lead a biologics manufacturing function, ensuring delivery of operational objectives in a safe, compliant and inspection-ready environment. Partner with cross-functional stakeholders to develop and execute manufacturing plans that support product lifecycle progression and commercial readiness. Lead and develop managers and manufacturing teams to achieve operational, quality and business objectives. Collaborate with MSAT and technical teams to execute technology transfer, process validation and commercial manufacturing activities. Support scale-up initiatives, equipment qualification and process performance qualification (PPQ) activities. Drive operational excellence, GMP compliance and continuous improvement across manufacturing operations. Ensure facilities, equipment and documentation remain audit and inspection ready. Build and develop organisational capability, including workforce planning, recruitment and succession planning. Manage departmental budgets, including CAPEX and OPEX planning. Experience & Qualifications MSc or equivalent in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences or related discipline. Significant experience within biologics, biopharmaceutical or advanced manufacturing environments. Proven leadership experience managing manufacturing teams and developing people leaders. Strong knowledge of GMP-regulated manufacturing operations. Experience supporting regulatory inspections and interactions with agencies such as FDA and EMA. Demonstrated experience in technology transfer, process validation, PPQ and manufacturing scale-up. Understanding of cell culture manufacturing processes, including fed-batch and/or perfusion platforms. Experience working in partnership with Manufacturing Sciences & Technology (MSAT) functions. Why Join? Opportunity to lead a high-performing manufacturing organisation within a growing biologics business. Significant influence over operational strategy, team development and manufacturing excellence. Exposure to commercial manufacturing, technology transfer and product lifecycle advancement.

Portfolio Strategy Director Location: UK or Major European Market (Home-Based) Travel: 20-30% International Travel Package: Competitive Base Salary + 22.5% Bonus + Car Allowance + Share Scheme Shape the Future of Innovative Medicines A leading global biopharmaceutical company is seeking a strategic and commercially minded Portfolio Strategy Director to help shape how pipeline assets are developed, positioned, and launched across Europe and international markets. Sitting at the intersection of portfolio strategy, market access, clinical development, and commercial planning, you'll help ensure future therapies are designed with payer requirements, reimbursement challenges, and commercial success in mind from an early stage. The Opportunity Acting as the regional voice within global development teams, you'll influence product strategy, evidence generation, clinical trial design, and launch planning across a diverse portfolio of innovative assets. Working closely with Commercial, Medical, Market Access, Regulatory, and Development teams, you'll help maximise asset value, overcome access barriers, and support key portfolio growth initiatives, including external asset evaluations and licensing opportunities. Key Responsibilities Shape portfolio and asset strategies across Europe and international markets. Influence Phase II/III development programmes to support future access and commercial success. Develop evidence-generation, pricing, and value strategies. Identify and address market access challenges early in the asset lifecycle. Support pipeline prioritisation and launch planning activities. Conduct market, payer, and competitive landscape assessments. Represent regional market needs within global strategic discussions. Support evaluation of business development and acquisition opportunities. About You You may come from portfolio strategy, new product planning, market access, commercial strategy, asset planning, or business development and will likely bring: Significant pharmaceutical or biotechnology industry experience. Strong understanding of European market access and reimbursement. Experience developing value and evidence packages to support pricing and access. Proven ability to influence development-stage assets and clinical programmes. Experience across major European markets, particularly Germany and France. Strong commercial acumen and stakeholder management skills. Desirable experience: Neurology or rare disease. Early asset or pipeline strategy. Lifecycle management. Licensing, acquisitions, or external innovation assessments. Why Join? Influence how future therapies are developed and commercialised. Work across multiple assets rather than a single brand. Shape strategy from Phase II/III development through to launch. Partner with senior global stakeholders on high-impact decisions. Gain exposure to both internally developed and externally acquired assets. Join an innovative organisation with an ambitious growth pipeline. If you're passionate about combining strategic thinking, market access expertise, and commercial insight to maximise the value of innovative medicines, we'd welcome a confidential conversation.

Staff / Senior Staff Sustaining Engineer | Medical Devices I’m partnering with a commercial-stage medical device company to hire a Staff or Senior Staff Sustaining Engineer. You’ll be the technical lead keeping a commercial disposable device line reliable, manufacturable and performing well in the field. THE ROLE You’ll own complex product issues end to end: complaints, CAPAs, field problems, supplier and material changes, and manufacturing issues. You’ll lead each one from root cause through closure, working across Quality, Manufacturing, Regulatory, Supply Chain and R&D. The environment moves fast and priorities can shift quickly, so you’ll need to be comfortable reprioritizing while keeping ownership. RESPONSIBILITIES Lead sustaining engineering for commercial products Investigate and resolve complaints, field issues, manufacturing problems and customer escalations Lead CAPA, root-cause analysis, corrective actions and effectiveness checks Evaluate and implement material, component, supplier and process changes, including risk assessment and V&V Drive biocompatibility, sterility and sterile barrier testing, coordinating with external test labs Perform design verification, design validation and process validation, and prepare documentation for regulatory submissions Analyze complaint, manufacturing and field data to spot trends early Support product improvements, cost reductions, supply continuity and obsolescence management Maintain specifications, drawings, risk files and test methods Mentor engineers and guide cross-functional teams QUALIFICATIONS BS or higher in Mechanical, Biomedical, Materials, Manufacturing or related engineering 8+ years of experience for Staff, 10+ for Senior Staff Broad sustaining, product, manufacturing or quality engineering experience on commercial products Strong track record with CAPA, root-cause investigations, complaints and field issues Experience implementing material, supplier or process changes Proven ability to lead cross-functional issues to closure Experience in a regulated development or manufacturing environment PREFERRED Disposable or single-use medical device experience ISO 13485, FDA QSR, design controls and risk management Polymers, adhesives, molded components, assemblies or packaging Product or mechanical design background Statistical methods and data analysis

Analog Front-End (AFE) Test Engineer | Neurotech / BCI | San Diego, CA (Onsite) I’m partnering with a venture-backed neurotechnology company developing an implantable brain-computer interface for people with severe paralysis. The company is in clinical trials and is building out a San Diego R&D team for its next-generation platform. They’re looking for an early-career engineer with strong analog fundamentals to own in-house testing of a custom neural recording chip. It’s a hands-on bench role and a strong first industry job for someone coming out of a graduate program or research lab. You’ll be mentored directly by the company’s senior chip lead. WHAT THE JOB IS An outside design firm builds the chip. Your job is to verify it independently. You’ll set up the lab, power up the first chips, and measure how well they actually perform against spec, using your own equipment and methods. RESPONSIBILITIES Build and maintain the bench setups, fixtures and instrumentation used to test the chip Help write test plans and protocols with the chip lead Measure key analog performance across every channel: noise, CMRR, power consumption, crosstalk Support testing of the chip as part of the full system, including the electrode array Write clear test reports that feed the company’s design documentation Grow into the owner of the full analog test program as the chip moves toward production QUALIFICATIONS BS, MS or PhD in Electrical Engineering, Bioengineering or related field Coursework, thesis or research in analog front-end or biopotential amplifier design, such as low-noise or chopper amplifiers, or SAR or delta-sigma ADCs Familiarity with electrode impedance and the electrode-tissue interface (e.g., EIS, equivalent circuit modeling) Hands-on lab experience with oscilloscopes, source-measure units, signal generators and noise measurement Python or MATLAB for data analysis and test automation No industry experience required. Medical device training is provided. WHY CONSIDER IT Hands-on ownership of first silicon on a novel neural interface program Direct mentorship from a senior chip lead A growing San Diego team working on technology that restores function for patients

ASIC Technical Lead | Neurotech / BCI | San Diego, CA (Onsite) I’m partnering with a venture-backed neurotechnology company developing an implantable brain-computer interface for people with severe paralysis. The company is in clinical trials and is now scaling a San Diego R&D team to build its next-generation platform. They need an experienced ASIC engineer to serve as the technical owner of a custom neural recording chip. A specialist IC design firm handles the design execution. This person is the company’s in-house expert who makes sure the chip is right. WHAT THE JOB IS You won’t be designing the chip yourself. You’ll define what it needs to do, scrutinize the partner’s work at every stage, and decide when it’s ready for fabrication. When silicon comes back, you’ll lead the effort to confirm it performs as intended and get to the bottom of anything that doesn’t. RESPONSIBILITIES Write and maintain the chip requirements and specification, with full traceability Lead technical reviews with the design partner from architecture through final sign-off, digging into the underlying schematics and simulation data Evaluate simulation, physical verification and design-for-test work, and own the decision to proceed to fabrication Identify and manage technical risks such as noise, power, matching and process variation across a large channel count Work with the in-house test engineer on silicon bring-up and characterization, and lead debug when issues come up Drive any required design revisions and the plan to re-verify them Support the chip through qualification and production, and define requirements for future generations QUALIFICATIONS BS or MS in Electrical Engineering or related field, with a focus on IC design 5+ years of ASIC or SoC experience, including at least one chip taken from concept through silicon An analog or mixed-signal IC design or verification background Experience reviewing simulation results (SPICE/Cadence), physical verification (DRC/LVS) and DFT Experience managing an outside design partner, foundry or fab Bonus: medical device experience (design controls, FDA submissions) or implantable electronics WHY CONSIDER IT Early role on a next-generation BCI program High-impact technical ownership of a novel neural recording chip A growing San Diego team working on technology that restores function for patients

Senior R&D Electrical Engineer – San Diego, CA I’m hiring a Senior R&D Electrical Engineer for an implantable neurotechnology company developing next-generation implantable electronics. This is a hands-on, technically deep role owning the electrical and programmable-logic design of the implant from concept through design verification. What You’ll Do Architect and develop synthesizable HDL (VHDL or SystemVerilog) for a low-power FPGA serving as the implant’s health, status, control, and communications controller Implement supervisory functions: power sequencing, voltage/current/temperature monitoring, watchdogs, fault detection, and safe-state transitions Define and implement the implant side of a high-speed serial link to distributed sensing electronics, proven in FPGA emulation with silicon partners ahead of hardware Design fault-tolerant control and monitoring logic, including redundant monitors, independent shutdown paths, and fail-safe defaults; lead FMEA and fault-tree analysis per ISO 14971 Own the implant’s electrical architecture, including custom silicon integration, inductive charging, RF telemetry, and power budgeting Lead miniaturized PCB and flex-rigid design in Altium Define and execute electrical and FPGA verification plans within design controls (IEC 60601-1, IEC 62304, ISO 14708) Review and debug firmware and test software alongside the firmware team; support design transfer to contract manufacturers What You Bring BS in Electrical Engineering, Computer Engineering, or related field 8+ years in mixed-signal hardware design for miniaturized, high-reliability electronic systems 5+ years of hands-on FPGA development on low-power families, including timing closure, clock-domain crossing, and simulation-based verification Serial interface design experience: LVDS/CML signaling, source-synchronous or CDR schemes, framing and error detection, SPI/I2C, register maps Design of safety-relevant or fault-tolerant digital systems Hands-on inductive power transfer or resonant/magnetics design High-density PCB and flex design in Altium; SPICE and signal-integrity analysis Ability to read, debug, and review embedded C firmware Experience taking electronic subsystems from prototype through design verification into production Nice to Have Active implantable device experience (neurostimulators, cochlear implants, cardiac rhythm devices) Custom silicon co-design and FPGA emulation of partner RTL Functional safety standards (IEC 60601-1 PEMS, IEC 61508, ISO 26262, DO-254) Implantable or body-worn antenna/RF design with EM simulation (HFSS, CST, COMSOL) Coil design and EM/thermal modeling, including MRI compatibility Low-noise neural or bioelectric front-end design Experience supporting IDE, PMA, or 510(k) submissions

Staff/Principal Mechanical Engineer – Medical Device Startup | San Diego, CA (Onsite) I’m partnering with a venture-backed medical device startup in San Diego developing a wearable automated insulin delivery system that makes life with diabetes simpler and safer. Their product has reached clinical studies, and they’re now hiring a Staff/Principal Mechanical Engineer to carry the hardware system through verification and into volume manufacturing. The Role You’ll be the hub of the hardware design: the system integrator who brings together user needs, risk analysis, mechanics, electronics, and industrial design into one cohesive product, while staying hands-on in detailed design, analysis, and debugging. What You’ll Do Integrate mechanisms, electronics, motion, fluidics, and packaging into a cohesive, user-centered product Translate user needs into design requirements, partnering with industrial design Lead risk analysis to drive design decisions and mitigations from the earliest stages Own electronics integration within the mechanical system alongside electrical engineering Design molded and machined assemblies using tolerance analysis as a core design tool Partner with regulatory, quality, and manufacturing on design controls, V&V, biocompatibility, sterilization, human factors, and design transfer Coordinate projects, timelines, and budgets; mentor junior engineers as the team grows What You Bring BS in Mechanical Engineering or related field (MS a plus) 8+ years of mechanical product design experience, including medical devices or other safety-critical systems Track record taking a product from design through verification into volume manufacturing Experience as the technical integrator across mechanical, electrical, industrial design, and user requirements Experience designing mechanisms and moving assemblies, ideally compact motorized electromechanical devices Deep hands-on expertise with molded and machined parts and advanced tolerance analysis Working knowledge of design controls, V&V, risk analysis, biocompatibility, sterilization, and human factors

Interim Head of Quality Location: Europe (On-site, Mediterranean region) Contract Duration: 4–6 months Start Date: ASAP Industry: Pharmaceutical Manufacturing Day Rate: Competitive, dependent on experience The Opportunity We are supporting an established European pharmaceutical manufacturer in the appointment of an experienced Interim Head of Quality during a critical period of business transformation. The organisation is undertaking a significant quality improvement and remediation programme, with multiple workstreams focused on strengthening quality systems, regulatory compliance and operational performance. This is a high-impact leadership opportunity for an experienced interim professional to provide stability, direction and strategic oversight while the business transitions towards a permanent leadership structure. Key Responsibilities Provide interim leadership across a multidisciplinary Quality function encompassing QA, QC, Microbiology, Quality Systems, Validation and Compliance. Lead and oversee a comprehensive quality remediation programme, ensuring effective execution of multiple concurrent improvement initiatives. Manage ongoing product quality issues, including recalls, investigations and associated corrective actions. Work closely with external consultants and internal stakeholders to prioritise remediation activities and deliver sustainable improvements. Strengthen quality governance, operational processes and regulatory compliance across the manufacturing site. Provide leadership, coaching and stability to a large Quality organisation during a period of significant change. Support recruitment and organisational development across senior Quality leadership positions. Collaborate closely with executive leadership to provide visibility on remediation progress, risks and priorities. Establish a culture of accountability, transparency and continuous improvement. Candidate Requirements Essential Experience Extensive senior Quality leadership experience within pharmaceutical manufacturing, ideally in generics or a similarly regulated environment. Proven track record of leading complex quality remediation, turnaround or transformation programmes. Experience managing large, multidisciplinary Quality teams within a manufacturing environment. Strong working knowledge of GMP, regulatory inspections, quality systems and compliance requirements. Demonstrable experience managing product recalls, quality investigations and CAPA programmes. Previous experience operating as an Interim Head of Quality, Quality Director or equivalent senior leadership position. Excellent stakeholder management, communication and decision-making capabilities. Personal Attributes Confident, pragmatic leader capable of establishing credibility quickly. High emotional intelligence and the ability to navigate sensitive organisational challenges. Comfortable operating in complex, fast-moving environments. Hands-on leadership approach with the ability to balance strategic oversight and operational delivery. Strong relationship-building skills across executive, technical and operational teams. Additional Information Significant on-site presence required, typically 3–4 days per week. Candidates must be comfortable with regular travel or temporary relocation. Qualified Person (QP) status is not required. Additional European language skills would be advantageous but are not essential. Competitive contract rates available for candidates with relevant transformation and remediation experience. Why Consider This Opportunity? This assignment offers the opportunity to make a tangible impact within an established pharmaceutical manufacturer undergoing significant operational change. The successful individual will play a central role in restoring confidence, strengthening quality operations and creating a sustainable foundation for long-term regulatory and operational excellence.

Senior Clinical and Regulatory Programme Manager Location: London, UK Contract: 1 year FTC with potential to extend. Location: on-site 5 days per week London Bridge. Benefits include: • 30 days annual leave • 4 additional concessionary days between Christmas and New Year • Bank holidays • Generous pension scheme • 3 paid volunteering days per year • Discount programme • Travel, cycle and car schemes An exciting opportunity has arisen for an experienced Clinical Trial Manager to join a highly ambitious, well-funded international research programme focused on clinical trials, digital health, AI, wearable technology and population health. This is a senior, hands on role suited to someone who wants to operate beyond traditional site delivery. The successful candidate will support the operational delivery and regulatory oversight of clinical trials, including observational and interventional sub-studies, while helping to build the governance, quality and regulatory infrastructure required for a complex multi-partner research programme. The role will involve managing day-to-day trial operations, supporting study set-up, overseeing site feasibility, activation and close-out, maintaining TMF/eTMF documentation, monitoring recruitment and retention, ensuring data quality and compliance, and working closely with academic, clinical, commercial and regulatory stakeholders. A key part of the position will be preparing and submitting regulatory and ethics applications, supporting audit and inspection readiness, contributing to SOP and QMS development, and ensuring trials are delivered in line with GCP, GDPR and relevant regulatory requirements. Key responsibilities include: • Managing day-to-day clinical trial operations across observational and interventional studies • Supporting site feasibility, selection, initiation, monitoring oversight and close-out • Preparing and submitting regulatory and ethics applications, amendments and progress reports • Maintaining TMF/eTMF documentation and version control • Monitoring recruitment, retention, protocol compliance and trial performance • Supporting implementation and use of EDC and mobile data capture platforms • Ensuring data integrity, privacy, GDPR compliance and inspection readiness • Developing and maintaining SOPs, trial processes and quality frameworks • Coordinating communication between academic teams, clinical sites, partners and regulatory bodies • Supporting trial budgets, reporting, governance meetings and stakeholder updates • Supervising or mentoring junior clinical research staff as the programme grows Essential experience: • Strong clinical trial management experience • Experience across the full trial lifecycle, from set-up to delivery and close-out • Hands-on experience with regulatory and ethics submissions, such as MHRA, REC or international equivalents • Strong understanding of GCP, clinical trial governance and regulatory compliance • Experience managing TMF/eTMF documentation and essential study files • Experience with site set-up, monitoring oversight, recruitment tracking and compliance • Strong IT and data management skills, including EDC or CTMS platforms • Experience developing or maintaining SOPs, work instructions or quality processes • Ability to work effectively across academic, clinical, commercial and regulatory stakeholders Desirable experience: • Academic, NHS, university, sponsor-side or investigator-led trial experience • Experience in multi-site or international clinical research programmes • Exposure to digital health, remote trials, wearable technology, AI-enabled studies or MedTech • Experience contributing to QMS development or inspection readiness • Experience in population health, maternal health, paediatrics or digital clinical studies • Experience mentoring or managing junior clinical research staff This is a fantastic opportunity for a Clinical Trial Manager who wants to step into a broader programme-level role with genuine ownership across clinical operations, regulatory submissions, governance and quality. To find out more, please apply or get in touch directly.

Director of Software (San Diego, CA — On-site) An innovative medical device company at a growth inflection point — with a product already in clinical studies — is seeking a Director of Software to lead and scale their software organization. This is a builder's leadership role reporting to the VP of R&D, combining hands-on technical depth with people leadership as the team grows from lean and high-performing into full commercial scale. What you'll own: Build and scale the software team — hiring, mentoring, and establishing a culture where engineers do their best work Drive engineering effectiveness — coding standards, workflows, and AI-enabled acceleration Translate executive vision into actionable technical strategy and roadmaps Stay technically hands-on — prototype, review, and build alongside the team Represent software cross-functionally with hardware, data science, regulatory, and executive stakeholders Own team budget, resource allocation, and delivery timelines What we're looking for: Bachelor's degree in Computer Science, Software Engineering, or related field 10–15+ years in software development, including 5+ years managing technical teams Experience shipping mobile apps and cloud backends end-to-end, ideally for a connected-device fleet Regulated industry experience — medical device or other safety-critical software strongly preferred Fluency in modern DevOps, CI/CD, and automation testing Comfort applying AI tools safely and effectively within a regulated environment 📍 Must be local to or willing to relocate immediately to San Diego, CA — this is an on-site role.

Sr. Process Development Engineer, Catheter Engineering San Francisco Bay Area (East Bay), onsite | Full-time Position Summary An innovative medical device company is hiring a Sr. Process Development Engineer to help bring its next-generation catheter technology to market. This role bridges early-stage development and commercial manufacturing: you’ll take early clinical catheter devices and refine them into robust, manufacturable products ready for launch. It’s ideal for someone with deep catheter engineering expertise, a manufacturing mindset, and a track record of successful design transfer. Responsibilities Lead process development to move catheter devices from first-in-human configurations to scalable commercial products Perform DFM/DFA analyses and tolerance stack-ups (worst-case and statistical), and define critical dimensions and component acceptance criteria Develop component specifications, drawing requirements, and incoming inspection criteria, including AQL sampling plans Characterize and optimize catheter processes: extrusion, braiding, tip forming, thermal bonding, adhesive joining, and laser cutting Develop electrical assembly processes for catheter-integrated components, including fine-gauge wire termination, surface-mount placement, and high- and low-voltage cable assembly Partner with Manufacturing Engineering on process validation (IQ/OQ/PQ), pFMEAs, SPC, capability studies (Cp/Cpk), and yield targets Develop inspection gauges and conduct MSA and gauge R&R studies Evaluate and qualify materials, adhesives, and components for processability and biocompatibility Manage ECOs while maintaining design history file integrity Ensure compatibility with sterilization methods (EO, gamma, e-beam) and packaging requirements Apply Lean principles to reduce waste and cycle time for commercial scale-up Partner with suppliers and contract manufacturers on process capability and continuous improvement Create work instructions, assembly procedures, and process travelers for design transfer Mentor junior engineers and technicians on problem solving and root cause analysis Requirements BS in Mechanical, Biomedical, Materials Science, or Manufacturing Engineering, or a related field; MS preferred 5+ years of medical device process development or manufacturing engineering experience, including 3+ years on catheter-based devices Proven experience taking a device from early-stage development to commercial manufacturing Hands-on catheter manufacturing experience: extrusion, braiding, thermal bonding, tip forming, adhesive assembly, and laser processing Proficiency in tolerance stack-up analysis and statistical methods (Cp/Cpk, SPC, gauge R&R); DOE a plus Experience supporting IQ/OQ/PQ in a regulated environment Familiarity with 21 CFR 820, ISO 13485, and ISO 14971 SolidWorks and GD&T (ASME Y14.5); Minitab preferred Working knowledge of catheter materials: PEBAX, nylon, polyurethane, PTFE, nitinol, stainless steel, platinum-iridium, and adhesive systems Root cause analysis tools: FMEA, fishbone, 8D, 5 Whys Cleanroom experience (ISO Class 7/8) preferred Strong project management and communication skills Up to 15% travel for supplier and contract manufacturer activities Compensation and Location Base salary of $130K–$155K, plus stock options and ESPP Onsite in the East Bay. Candidates must live in the SF Bay Area; relocation isn’t offered.

Senior Data Engineer | Medical Device Startup | San Diego, CA (Hybrid, 3+ days onsite) A venture-backed startup developing a novel wearable medical device is hiring a Senior Data Engineer. The company is running multiple clinical trials leading toward a pivotal FDA submission. THE ROLE This role owns the company's data architecture end to end and reports to the Director of Data Science. The work starts upstream: you'll make sure the right data is collected in the first place by turning clinical, regulatory and commercial needs into instrumentation specs, then build the infrastructure that makes that data useful. It's hands-on. You'll design schemas and implement them, contribute to product concepts, and build several systems from scratch. The data includes telemetry from embedded and mobile systems with intermittent connectivity, clinical outcomes, EDC data, and evolving manufacturing and production systems. WHAT YOU'LL DO Define what data to collect from the device, manufacturing and business operations, and translate those needs into instrumentation specs and data models Design and own data schemas that serve analytical, regulatory and operational users, and document the tradeoffs Build and maintain transformation pipelines on Google Cloud and BigQuery Own the warehouse layer, including schema implementation, versioning, access controls and data quality monitoring Keep lineage and transformation logic traceable to a standard that holds up in a regulatory audit Build integrations with EDC systems and third-party device data Produce CDISC-compliant datasets (SDTM/ADaM) for regulatory submissions Build manufacturing data infrastructure: lot tracking, supply chain, process control and non-destructive testing records Define data quality metrics and checks, own the fixes, and step into analysis when the team needs it WHAT YOU BRING 7+ years of data engineering experience, with a track record of owning production data systems end to end Experience defining data models and instrumentation requirements upstream of pipeline development Strong Python and SQL, plus working knowledge of cloud data platforms (the stack is Google Cloud, BigQuery and Firestore) Strong data modeling skills, with the judgment to serve multiple users and make tradeoffs explicit Experience turning business and scientific requirements into specs across data science, engineering, operations, clinical and regulatory teams Clear, direct communication with non-technical stakeholders NICE TO HAVE Experience in a regulated industry (medical devices, pharma or clinical research) where auditability and traceability are required Familiarity with CDISC (SDTM/ADaM) or clinical trial data formats Experience with EDC systems such as Castor, REDCap, Medidata Rave or Veeva Vault Exposure to 21 CFR Part 11 Experience with manufacturing, supply chain or operational data systems Background in medical devices, wearables or digital health MS in computer science, data engineering, biomedical informatics or a related field Candidates must be authorized to work in the U.S. without sponsorship and must live within commuting distance of San Diego.

Clinical Research Associate (CRA) – Medical Devices Location: Germany (Home-based with travel to investigator sites 30-50%) Anticipated Start Date: November 2026 Contract: Consultant / Freelance / Sole trader About the Opportunity Johnson & Johnson are seeking an experienced Clinical Research Associate (CRA) to support the delivery of clinical studies across Germany. This role will focus on clinical monitoring activities at investigator sites and offers the opportunity to work on innovative medical device studies within a dynamic clinical research environment. Key Responsibilities As the Clinical Research Associate, you will be responsible for: Conducting Site Initiation Visits (SIVs) Performing Interim Monitoring Visits (IMVs) Executing Close-Out Visits (COVs) Managing investigator site relationships and communications Acting as a key liaison between sites and sponsor teams Participating in sponsor training activities Supporting overall study quality, compliance, and monitoring deliverables Requirements To be successful in this role, you should have: Minimum 5 years of clinical monitoring experience Strong experience conducting the full range of monitoring visit types, including: Site Qualification Visits (SQVs) Site Initiation Visits (SIVs) Interim Monitoring Visits (IMVs) Close-Out Visits (COVs) Bachelor's degree in Life Sciences or a related scientific discipline Essential experience monitoring medical device studies Excellent site management and stakeholder communication skills Ability to work independently across multiple investigator sites Working Arrangements Home-based role with travel to hospital sites throughout Germany Flexible resource requirement averaging between 50% and 100% FTE Different availability levels will be considered, including consultants seeking part-time assignments Anticipated contract start in November 2026

Director of Product Quality Engineering | San Diego, CA (100% onsite) Summary We've been exclusively retained by an established diagnostics company to find a Director of Product Quality to lead its San Diego site's quality engineering and quality control organization. It's a hands-on leadership role for an engineer at heart: someone with deep validation and statistics expertise who can answer the tough technical questions, mentor a large team, and stay calm and credible during FDA inspections. The site is in a period of growth and change, having recently added several key leaders that are incredibly high caliber. You'd join a leadership team of decision makers and play a key role in raising the bar on quality across the site, with real room to grow. 💰 $200K–$260K base + bonus and industry-leading benefits Scope Leads a 36-person Quality Engineering and Quality Control organization 4 direct reports: 2 Senior Managers and 2 Specialized Engineers Oversees: incoming QC, supplier quality, Quality Control, design quality, and product quality and reliability Responsibilities Lead, develop and mentor a team of people leaders and engineers, and be the technical leader the team looks up to Serve as the site's subject matter expert on statistics and process validation, guiding the team on capability analysis, SPC and validation strategy week to week Oversee process validation, design controls, design quality and ISO 14971 risk management for new and sustaining products Sit on the site's CAPA Review Board alongside senior Operations and R&D leaders, driving root cause rigor and CAPA effectiveness across all phases Maintain oversight of nonconformance management (NCRs handled by QC) Lead FDA and ISO inspection readiness, and act as a calm, credible point of contact during inspections and audits Partner with Supply Chain and R&D on supplier selection, auditing and performance monitoring Champion Lean Six Sigma and 5S initiatives across the site Work closely with Manufacturing, Operations, R&D and Regulatory to improve quality and business performance Requirements BS in Engineering strongly preferred; BS in a technical discipline required 15+ years of quality engineering and quality control experience in medical device or IVD manufacturing (FDA/ISO 13485) 10+ years of people leadership, including managing managers Hands-on validation experience, including authoring process validation protocols (IQ/OQ/PQ) and leading validation strategy Expert-level statistics in practice: process capability (Cpk/Ppk), SPC, DOE and sampling plans Strong foundation in ISO 14971 risk management, CAPA and root cause investigation Direct experience leading or supporting FDA inspections Working knowledge of mechanical inspection, engineering drawings, GD&T and tolerancing ASQ CQE strongly preferred; Six Sigma Black Belt a plus Lean / 5S experience a plus What success looks like Credible and hands-on: can answer technical questions on validation, statistics and drawings, not just delegate them Calm under pressure: unruffled during inspections, and a steady mentor to the team Courageous and transparent: comfortable challenging and being challenged in a room of senior decision makers Influential: builds trust and alignment across Operations, R&D and Quality

🚨 Hiring: Senior / Staff Manufacturing Engineer | San Diego, CA I'm partnering with a venture-backed medical device startup developing a novel wearable device. They're already in clinical studies and building product on their own pilot line, and they're looking for a hands-on Manufacturing Engineer to own that line as they scale toward larger trials and commercial launch. This is an engineering role first. Your main focus will be manufacturing engineering, fixture design and equipment, with the added ownership of running a small, high-performing pilot line. You won't be starting from zero: the line is up and running, and the opportunity is to solve problems, optimize, and build in quality that will scale. 📍 San Diego, CA | Onsite 💰 $130K–$160K base + equity 🎚️ Senior or Staff level, 4–7+ years of experience 🚚 Relocation assistance available What you'll do Own day-to-day pilot line operations, including build planning, material forecasting and tracking output against plan Train and develop two high-performing operators into line leads Design and build fixtures and equipment for small electromechanical and single-use components Troubleshoot build issues and drive practical improvements in yield and efficiency Source and bring new equipment online, such as heat sealers, adhesive dispensers and label printers Own calibration, maintenance and good documentation practices on the line Write and execute validations (IQ/OQ/PQ, PFMEA, TMV) and support cleanroom qualification Shift toward scale-up and automation as the company builds out a full operations team over the next 1–2 years What you'll bring BS in Mechanical Engineering or a related field 4–7+ years of hands-on manufacturing engineering experience in medical devices, including calibration, process validation and good documentation practices Experience taking a product from development into production Fixtures you designed that went into daily production use Experience training operators directly on the line Exposure to both established, larger-scale production lines and fast-moving, scrappy R&D environments Proficiency in SolidWorks Strong problem solver who is comfortable wearing multiple hats and works well with people Bonus: cleanroom and ESD experience Why this role Build the manufacturing foundation for a product that will change patients' daily lives High ownership and visibility in a lean, mission-driven team Meaningful equity at an early stage

Senior Director, Regulatory Advertising & Promotion Location: Remote, US (East and Central Time Zones) Industry: Biotechnology / Rare Disease A global biopharmaceutical organization is seeking an experienced Regulatory Advertising & Promotion leader to oversee its Ad/Promo function and provide strategic regulatory leadership across promotional, medical, and corporate communications. This highly visible role will lead an established team while partnering closely with Commercial, Medical, Legal, Regulatory, and senior leadership. Key Responsibilities Lead and provide strategic direction to the Regulatory Ad/Promo team . Own and evolve the global material review process across promotional and non-promotional communications. Provide strategic, risk-based regulatory guidance on promotional activities and product communications. Oversee regulatory review and approval of US promotional, corporate, and medical materials. Lead interactions with FDA OPDP/APLB , including proactive engagement and regulatory inquiries. Serve as regulatory lead on review committees and escalation discussions. Partner cross-functionally to balance business objectives with regulatory requirements. Develop and enhance SOPs, work instructions, and review processes. Qualifications 15+ years of pharmaceutical/biopharmaceutical industry experience, including 5+ years in Regulatory Advertising & Promotion . Deep knowledge of FDA promotional regulations, guidance, and evidentiary standards supporting product claims . Significant promotional and medical review experience. Experience interacting directly with FDA OPDP/APLB . Proven people leadership and cross-functional stakeholder management. Strong judgment and ability to navigate regulatory gray areas through thoughtful risk assessment and mitigation . BS in a scientific discipline required; advanced scientific degree or JD preferred. Rare Disease, Hematology, and/or Oncology experience is a plus. Experience with AI and digital tools is advantageous. Ideal Profile Seeking a collaborative, solutions-oriented Ad/Promo leader who combines deep regulatory expertise with strong business judgment. The ideal candidate can lead autonomously, influence senior stakeholders, develop an experienced team, and provide practical regulatory solutions rather than simply identifying risk.

Senior Director, Business Development Boston, Massachusetts About the Opportunity A clinical-stage biotechnology company is seeking an accomplished Senior Director, Business Development to join its growing global organization. This is a highly visible, externally facing role focused primarily on asset-level business development and out-licensing across a growing portfolio of preclinical and clinical-stage therapeutics. The successful candidate will identify and originate new partnering opportunities, develop relationships across the pharmaceutical and biotechnology ecosystem, and lead transactions from initial outreach through diligence, negotiation, execution, and post-deal transition. The position is best suited for a scientifically credible, commercially driven BD leader who combines a strong network with the ability to operate hands-on in a fast-moving biotechnology environment. Key Responsibilities Lead out-licensing and strategic partnering activities for preclinical and clinical-stage therapeutic assets. Originate new opportunities and proactively identify pharmaceutical and biotechnology partners aligned with individual assets and portfolio strategy. Own transactions throughout the deal lifecycle, including partner identification, outreach, evaluation, due diligence, valuation, negotiation, and execution . Develop compelling partnering strategies and positioning for individual therapeutic programs. Build and maintain senior-level relationships across biotechnology, pharmaceutical, investment, and broader life sciences organizations. Partner closely with scientific, clinical, finance, legal, and executive leadership throughout transaction processes. Evaluate market, competitive, scientific, and commercial intelligence to inform BD and portfolio strategy. Develop financial models and assess deal structures, economics, and strategic value. Support broader strategic transactions, collaborations, and potential M&A activities as needed. Provide mentorship and guidance to more junior members of the Business Development organization. Represent the organization at industry conferences and external partnering meetings. Operate effectively across a global and highly cross-functional organization. This individual will be at the center of deal execution while partnering closely with R&D, legal, finance, management, and external parties. Candidate Profile Advanced scientific degree strongly preferred, ideally a PhD in Biology, Medicinal Chemistry, Chemistry, or a related scientific discipline . Approximately 10+ years of biotechnology/pharmaceutical industry experience , with significant experience in Business Development, licensing, or strategic partnerships. Demonstrated track record of personally leading or materially contributing to large out-licensing transactions involving therapeutic assets . Proven ability to originate opportunities , rather than relying solely on inbound, inherited, or pre-existing transactions. Strong existing network of decision-makers and partnering contacts across biotechnology and pharmaceutical organizations. Deep understanding of the drug discovery and development lifecycle with the scientific fluency to assess assets and identify appropriate potential partners. Experience developing asset partnering strategies, financial models, valuations, and deal structures. Combination of large pharmaceutical and biotechnology experience strongly preferred. Commercially aggressive and entrepreneurial while remaining scientifically credible. Comfortable operating hands-on without extensive infrastructure or layers of support. Strong executive presence, negotiation skills, and ability to influence senior internal and external stakeholders. Experience mentoring or developing junior BD professionals. The position will involve periodic travel for conferences, partnering meetings, and client discussions. The formal specification identifies Boston as the location and emphasizes the ability to work independently while collaborating across a globally distributed organization.

Director, Medical Education Business Development BioTalent is partnering with a leading organization in the healthcare education space to identify a Director, Medical Education Business Development . This is an excellent opportunity for an experienced business development professional looking to join a collaborative, entrepreneurial team with strong earning potential and the autonomy to make an impact. Key Responsibilities Drive new business growth while managing and expanding strategic client relationships (approximately 70% new business / 30% account management) Sell medical education solutions to pharmaceutical and life sciences organizations Build and maintain long-term partnerships with key industry stakeholders Represent the organization at conferences and client meetings What We're Looking For 5–7 years of business development experience Background in CME preferred; candidates from Medical Affairs, healthcare advertising, or other adjacent life sciences industries are also encouraged to apply Demonstrated success generating new business and exceeding sales goals Experience selling into pharmaceutical and biotech organizations Oncology experience is a plus, but not required What the Role Offers Entrepreneurial culture with the autonomy to sell to your strengths Established market presence and strong brand recognition Existing accounts provided while continuing to develop new business Remote opportunity (EST/CST preferred) with approximately 20–25% travel Competitive compensation with u ncapped monthly commission If you have a proven track record in healthcare business development and are interested in learning more, we'd love to connect. Please reach out directly or apply to start a confidential conversation.

Location: San Diego, CA (On-site) Summary We're seeking a Staff Engineer to serve as the primary technical owner of our next-generation medical device platform's electronics and firmware system — spanning board-level hardware, embedded firmware, and system integration. This is a hands-on, individual-contributor technical ownership role (not people management), where you'll be the central technical point of contact for our external electronics and firmware development partners, taking boards from design through bring-up, integration, and verification. Responsibilities Serve as the primary technical point of contact for external electronics and firmware development partners, reviewing and approving their schematics, PCB layouts, and firmware architecture Own board-level architecture decisions, board bring-up, debug, and validation using lab equipment (oscilloscopes, logic analyzers, multimeters) Own firmware and software architecture and technical roadmap, including driver, RTOS, connectivity, and UI integration work Own system integration end-to-end, diagnosing and resolving issues spanning the hardware/firmware boundary Define and track system-level integration and verification test plans with Quality Keep development activities aligned with Design Controls, IEC 62304, and IEC 60601 requirements Support technical investigations for field issues, NCRs, and CAPAs Requirements Bachelor's degree in Electrical Engineering, Computer Engineering, or related discipline (or equivalent practical experience) 8+ years of combined hardware and embedded firmware experience Demonstrated experience managing or coordinating the technical work of external development/contract engineering partners Strong embedded C experience, including RTOS (e.g., FreeRTOS) and MCU peripheral configuration (GPIO, ADC, timers, PWM, UART, SPI, I²C, DMA, interrupts) Experience with STM32 or comparable MCU platforms Proven ability to bring up, debug, and troubleshoot circuit boards using standard lab equipment Ability to read and review schematics and PCB layouts Medical device or other regulated product experience preferred Key Requirements Summary 8+ years combined hardware + embedded firmware experience Strong embedded C, RTOS (FreeRTOS), STM32/MCU peripheral work Board-level hardware: schematic/PCB review, bring-up, debug with lab equipment Experience managing external design firms/contract engineering partners Medical device/regulated industry experience strongly preferred (IEC 62304, IEC 60601)

A rapidly growing life sciences consultancy is looking to add Senior Consultants and Managers to its Operating Model Design practice. This team partners with pharmaceutical, biotech, and healthcare organisations to design and implement operating models that enable growth, improve effectiveness, and support strategic transformation. Typical project work includes: Commercial operating model design Organisational transformation Role and capability design Cross-functional ways of working Launch operating models Business transformation and implementation support We're looking for: Experience within life sciences consulting Exposure to operating model, organisational design, transformation, or commercial effectiveness projects Strong problem-solving and client-facing capabilities Experience managing project workstreams Desire to work in a hands-on, entrepreneurial consulting environment Why consider the opportunity? Opportunity to shape major transformation programmes across the life sciences sector Direct client interaction and leadership exposure Entrepreneurial, collaborative culture Strong investment in employee development Clear pathway for progression and long-term career growth If you're looking for an opportunity to have a visible impact within a growing consultancy, I'd be delighted to discuss the role in more detail.

I'm partnering with a growing life sciences consultancy that is looking to hire a Senior Analyst to support its Asset & Portfolio Strategy practice. This team works with leading pharmaceutical, biotech, and healthcare organisations to answer some of their most critical strategic questions, helping clients make informed investment decisions across products, portfolios, and therapeutic areas. The role offers exposure to senior stakeholders, high-impact strategic projects, and excellent opportunities for development within a growing consultancy. Typical project work includes: Portfolio strategy and optimisation Asset prioritisation and investment decision support Product and franchise growth strategy Business case development Opportunity assessments and market attractiveness analysis Commercial strategy across the product lifecycle We're looking for: 2-4 years of experience within life sciences consulting, healthcare consulting, or a related strategy environment Exposure to portfolio, brand, commercial, corporate, or product strategy engagements Strong analytical and problem-solving skills, with the ability to work through complex business questions Experience supporting project workstreams and developing client-ready analyses and recommendations Excellent communication skills and an interest in working closely with clients A passion for solving strategic challenges within the healthcare and life sciences sector Why consider the opportunity? Strong growth trajectory and expanding client base Exposure to high-impact strategic decision-making across pharmaceutical and biotech organisations Direct access to senior leadership and mentorship from experienced consultants Collaborative and entrepreneurial culture with significant responsibility from an early stage Clear progression opportunities and investment in professional development If you're interested in accelerating your consulting career within asset and portfolio strategy, I'd be happy to arrange a confidential discussion.

We are partnering with a leading global strategy consulting firm to identify experienced Principals to join a growing Operations & Supply Chain practice. This team advises C-suite leaders and senior executives on complex, high-impact supply chain and operational transformation initiatives, helping organisations improve performance, build resilience, accelerate growth, and create sustainable competitive advantage. This is a leadership opportunity for an experienced consulting professional with a strong track record of delivering large-scale transformation programmes, developing senior client relationships, and contributing to business growth. You will play a critical role in shaping client agendas, leading project teams, and growing the firm's presence across operations and supply chain strategy. What this role offers • Direct exposure to C-suite executives and senior decision-makers on mission-critical operations and supply chain challenges • The opportunity to shape strategic direction and lead complex transformation programmes across global organisations • Leadership responsibility across multiple client engagements, teams, and workstreams • The ability to influence and build long-term client relationships while driving business development activity • Involvement in practice-building initiatives, thought leadership, and capability development • Exposure to a diverse portfolio of industries and business challenges • A collaborative, entrepreneurial consulting culture with clear progression opportunities • Competitive compensation and the opportunity to build a long-term leadership career within a leading consulting firm Key Responsibilities • Lead end-to-end client engagements across supply chain, operations, and transformation programmes • Serve as a trusted advisor to senior client stakeholders, including C-suite executives and functional leadership teams • Originate and develop new client opportunities, supporting business development, proposal development, and sales activities • Lead multidisciplinary consulting teams and provide coaching and development to junior team members • Shape strategic recommendations and transformation roadmaps across key areas including: - Supply chain strategy and operating model design - End-to-end network optimisation - Demand planning, forecasting, and S&OP transformation - Inventory optimisation and working capital improvement - Procurement transformation and strategic sourcing - Manufacturing strategy and operational excellence - Distribution and fulfilment optimisation - Logistics and transportation strategy - Supply chain resilience and risk management - Digital supply chain and capability-building initiatives • Develop robust business cases and investment strategies to support transformation decisions • Translate complex analytical findings into actionable recommendations for executive audiences • Drive successful project delivery while managing client expectations, commercial performance, and team effectiveness • Contribute to thought leadership, market visibility, and the continued growth of the Operations & Supply Chain practice What You Will Bring • Significant experience within strategy consulting, management consulting, or a leading industry operations and supply chain environment • Strong expertise across one or more core supply chain disciplines, including strategy, planning, procurement, manufacturing, logistics, distribution, or transformation • Demonstrated experience leading large-scale operational and supply chain transformation programmes • Proven track record managing senior client relationships and acting as a trusted advisor to executive stakeholders • Experience leading consulting teams and developing high-performing talent • Strong commercial acumen with experience supporting business development, proposal writing, and sales activities • Exceptional analytical and structured problem-solving capabilities • Outstanding communication, stakeholder management, and executive presentation skills • The ability to influence, challenge, and engage senior decision-makers • A highly collaborative leadership style combined with an entrepreneurial mindset and passion for solving complex operational challenges This opportunity is particularly suited to consulting leaders who enjoy working at the intersection of strategy and execution, combining rigorous analytical thinking with practical transformation impact while helping clients solve some of their most complex supply chain and operations challenges.

A rapidly growing life sciences consultancy is seeking a Senior Analyst to join its Operating Model Design practice. This team partners with pharmaceutical, biotech, and healthcare organisations to design and implement operating models that enable growth, improve effectiveness, and support strategic transformation. The role offers the opportunity to work alongside experienced consultants on high-impact projects while developing a broad consulting toolkit. Typical project work includes: Commercial or Medical operating model design Organisational transformation Role and capability design Cross-functional ways of working Launch operating models Business transformation and implementation support We're looking for: 2-4 years of experience within life sciences consulting, healthcare consulting, or a related field Exposure to operating model, organisational design, transformation, commercial effectiveness, or change-related projects Strong analytical and problem-solving skills with the ability to structure complex challenges Experience supporting project workstreams and contributing to client deliverables Excellent communication and stakeholder management skills A desire to work in a hands-on, entrepreneurial consulting environment Why consider the opportunity? Opportunity to contribute to major transformation programmes across the life sciences sector Direct exposure to clients and senior leadership Entrepreneurial, collaborative culture with significant responsibility from day one Strong investment in training, mentorship, and professional development Clear career progression within a growing consultancy If you're looking to accelerate your consulting career and gain exposure to strategic transformation projects within the life sciences industry, I'd be delighted to discuss the opportunity in more detail.

Internal Sales, Marketing Specialist (Neuroscience) Position Overview A growing clinical research organization is seeking an Inside Sales and Marketing Specialist to build and lead its CRO relationship and marketing strategy. This remote role combines strategic relationship management, content development, conference planning, and commercial support within the neuroscience clinical research market. This position is well suited to a mid-career professional who wants to take long-term ownership of a function, build programs from the ground up, and become a trusted partner to CRO stakeholders. The role is more focused on relationship development and marketing than traditional quota-carrying sales. Key Responsibilities CRO Relationship Management Develop and maintain relationships with priority contract research organizations (CROs). Position the organization as a preferred clinical research site partner during feasibility assessments and bid-defense planning. Build and manage a target list of CRO accounts, stakeholders, and decision-makers. Establish recurring meetings with key CRO contacts. Coordinate the execution of master confidentiality disclosure agreements (CDAs). Track relationship activity, feasibility opportunities, site-selection outcomes, and related performance indicators in Salesforce. Partner with internal leadership on strategic CRO presentations and business development conversations. Increase awareness of the organization’s neuroscience capabilities among CRO clinical operations and feasibility teams. Marketing and Content Strategy Build the organization’s marketing infrastructure, processes, and calendar. Develop and manage a consistent LinkedIn posting schedule. Create a data-driven content strategy tailored to neuroscience sponsors and CRO audiences. Translate clinical research capabilities, performance data, and neuroscience expertise into compelling commercial content. Prepare presentations, marketing materials, and thought-leadership content. Use engagement and performance data to evaluate and improve marketing effectiveness. Conference Strategy Develop the annual strategy for approximately three to five industry conferences. Identify conferences with the strongest neuroscience, sponsor, and CRO audiences. Schedule meetings with priority contacts before each event. Coordinate messaging, outreach, presentations, and follow-up activities. Measure conference performance and recommend improvements to increase return on investment. Work with administrative support on travel and event logistics while retaining ownership of conference strategy. Qualifications Experience in clinical research, neuroscience, life sciences, contract research organizations, clinical trial site networks, biotechnology, pharmaceuticals, or a related field. Knowledge of neuroscience clinical development, ideally including Alzheimer’s disease, psychiatry, or other central nervous system indications. Understanding of sponsor priorities and CRO site-evaluation and selection processes. Experience developing CRO relationships or working directly within a CRO environment is strongly preferred. Ability to translate clinical research data and operational capabilities into effective marketing content. Strong presentation, relationship-building, and stakeholder-management skills. Experience creating professional presentations and leading external business conversations. Proficiency with Salesforce, Microsoft PowerPoint, and LinkedIn. Strong organizational skills and the ability to independently build new programs and processes. Willingness to travel to approximately three to five conferences annually. Preferred Background Previous experience working for a CRO, clinical trial site network, life sciences consultancy, biotechnology company, pharmaceutical company, or clinical research vendor. Experience spanning CRO operations, relationship management, consulting, marketing, or commercial strategy. Advanced scientific or clinical training in neuroscience or a related discipline is a plus. Demonstrated ability to communicate credibly with scientific, clinical, operational, and commercial audiences. Measures of Success Success will be evaluated through relationship and marketing milestones rather than a traditional sales quota. Initial objectives may include: Launching and maintaining a consistent LinkedIn content schedule. Establishing standing meetings with priority CRO partners. Securing five new master CDAs with target CROs. Increasing qualified feasibility opportunities. Improving selection rates for priority clinical research sites. Building a measurable and repeatable conference strategy. Strengthening awareness of the organization’s neuroscience research capabilities. Location and Travel Remote position with location flexibility. Travel to approximately 3 to 5 industry conferences per year. This is not a high-travel position.

Director of Clinical Affairs Can be based in San Francisco, CA or Boston, MA We're seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. This is a hands-on, operationally intense role for someone who has taken devices or SaMD from earliest-stage concept all the way through trial completion and into post-market surveillance — not just a single phase of the lifecycle. What You'll Do Own the full device/SaMD clinical lifecycle — from early-stage study design through trial execution, final study report, and post-market surveillance Develop study design from scratch in close collaboration with internal management, regulatory advisors, reimbursement specialists, and KOL advisory committees Lead clinical study execution — feasibility, site selection, activation, enrollment, monitoring, and close-out Write and manage IRB/Ethics submissions, informed consent forms, and study essential documents Select, qualify, and oversee third-party clinical sites and investigators as primary point of contact Manage clinical data operations — eCRF design, data review, query resolution, vendor coordination Develop study timelines, budgets, and risk mitigation plans, reporting clearly to leadership Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance Manage CRO and clinical vendor relationships, including contract negotiation and performance oversight Collaborate cross-functionally with regulatory, product, engineering, and legal teams Support RA/QA peers on FDA interactions, pre-subs, and 510(k) submissions Build and scale the clinical operations function — SOPs, templates, and tracking systems Maintain post-market surveillance activities, including adverse event monitoring and reporting What You Bring Minimum B.S. Degree with 10+ years hands-on clinical operations experience (5+ in leadership) running trials for FDA-regulated medical devices, SaMD/digital health, or combination products Demonstrated experience owning a device or SaMD through the complete lifecycle — from initial concept and study design through trial completion and post-market surveillance Track record of building study designs from scratch alongside key internal and external stakeholders Experience with biosensing devices, consumer health tech, or wellness platforms pursuing clinical validation Familiarity with RWE study designs and decentralized/hybrid trial models Startup or scale-up experience building processes from scratch Experience supporting breakthrough device designations or pre-sub meetings Experience launching studies across multiple regions/countries, with direct exposure to varying regulatory bodies and government requirements Track record of trials leading to FDA clearances/approvals or labeling expansions Experience managing third-party clinical sites end-to-end (selection through close-out) Proven ability authoring IRB/Ethics submissions, ICFs, and clinical protocols 7+ years cross-functional program management across clinical, engineering, and regulatory Strong clinical data management knowledge (eCRF, data cleaning, query management, database lock) Fluency in FDA device regulations (IDE, De Novo, 510(k)), ICH-GCP, ISO 14155, and SaMD guidance Experience with study budgeting, vendor management, and CRO oversight KOL relationship-building experience

I'm partnering with a growing life sciences consultancy that is looking to hire Senior Consultants and Managers to support its Asset & Portfolio Strategy practice. This team works with leading pharmaceutical, biotech, and healthcare organisations to answer some of their most critical strategic questions, helping clients make informed investment decisions across products, portfolios, and therapeutic areas. Typical project work includes: Portfolio strategy and optimisation Asset prioritisation and investment decisions Product and franchise growth strategy Business case development Opportunity assessments and market attractiveness analysis Commercial strategy across the product lifecycle We're looking for: Experience within life sciences consulting Exposure to portfolio, brand, commercial, or corporate strategy engagements Strong analytical and problem-solving capabilities Ability to manage workstreams and engage directly with clients Passion for solving complex strategic challenges within healthcare Why consider the opportunity? Strong growth trajectory and expanding client base Exposure to high-impact strategic decision-making Direct access to senior leadership Collaborative and entrepreneurial culture Clear progression opportunities If you'd be interested in a confidential discussion, please get in touch.

Senior Director, Regulatory Affairs (fully on-site in San Diego) Summary Our client is a well-funded, growth-stage medical technology company developing a Class III active implantable platform at the intersection of healthcare and advanced engineering. This role serves as the senior regulatory leader for the company's San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities. The Senior Director will own regulatory strategy for new platform development, oversee ongoing product updates and manufacturing-related submissions, and work closely with engineering, quality, and clinical teams to ensure regulatory readiness throughout the product lifecycle. Responsibilities Lead regulatory strategy and submission planning for software, firmware, and hardware across new product development programs and product updates Author and manage IDE, PMA, and PMA supplement submissions to the FDA; support additional international filings as needed Develop and execute software and firmware regulatory strategy for complex implantable devices, including AI/ML considerations, change management, and lifecycle documentation Provide regulatory support for manufacturing-related activities, including process changes and design transfers Partner with engineering, software, quality, clinical, and operations teams to integrate regulatory requirements from early development through commercialization Provide regulatory guidance on new product concepts, design inputs, and technology transfers Support project planning and roadmaps with well-defined regulatory milestones and risk assessments Monitor evolving FDA regulations, guidance, and international standards relevant to Class III implantable devices and complex software/firmware-driven medical technologies Ensure ongoing compliance with IDE and approved submission commitments, including reporting obligations Represent the company in FDA meetings, pre-submission interactions, and agency correspondence Minimal travel expected ( Requirements Bachelor's degree in engineering, life sciences, or a related field; advanced degree preferred 12+ years of regulatory affairs experience in the medical device industry, including demonstrated experience with complex Class II or III Medical Devices. Strong software and firmware regulatory expertise, including AI/ML-enabled features and applicable FDA guidance Track record of independently leading FDA submissions (IDE, PMA, supplements) and managing agency interactions Familiarity with manufacturing-related regulatory considerations (process changes, design transfers) in a device development or scale-up context Experience supporting new product development from concept through submission, including design control and risk management Deep knowledge of 21 CFR Parts 820, 812, 814, and applicable international standards Exceptional written and verbal communication skills; able to translate regulatory complexity for engineering and executive audiences Comfortable operating in a lean, startup-style environment Preferred : RAC certification (RAPS); experience with implantable neurotechnology or neural stimulation devices; familiarity with OUS pathways (CE Mark, TGA); experience scaling a regulatory function at a growth-stage company.

We are seeking a Senior Scientist to join our Protein & Vector Engineering team, contributing to cutting-edge research in structural bioinformatics, computational chemistry, and AI-driven drug design. This role plays a key part in advancing computational drug design (CDD) across biologics, chemistry, and genomics programmes. You will work closely with senior scientists and cross-functional teams to develop and apply innovative computational approaches for 3D structure prediction, molecular modelling, and protein/antibody design. What this role offers Senior-level ownership of computational strategy and execution Exposure to AI- and computation-driven drug discovery programmes A collaborative, multidisciplinary environment across protein engineering, genomics, and data science Opportunity to contribute to publications, patents, and platform development Key responsibilities Lead computational strategies for drug design, molecular modelling, and structural bioinformatics Design and execute advanced workflows (MD, QM, protein & antibody design, AI/ML-driven CDD) Mentor junior scientists and support technical development Build and maintain robust, reproducible in-house computational pipelines Collaborate with internal teams and external partners What you’ll bring PhD in a relevant computational or life sciences discipline 5+ years’ experience in computational drug design or molecular modelling Strong expertise in structural bioinformatics, computational chemistry, and AI/ML Programming skills in Python, R, or Bash Experience with tools such as Schrödinger, MOE, Rosetta, PyMOL, AlphaFold Nice to have HPC or cloud computing experience Peptide modelling End-to-end drug discovery exposure

I am seeking a senior-level, seasoned medical communications leader to lead and grow one large, complex pharmaceutical client account. This role is highly strategic and client-facing, focused on partnership, commercial impact, and delivery excellence across a broad portfolio of work. This person will operate with a high degree of autonomy and act as the primary day-to-day senior point of contact for their assigned account, pulling in expertise and support from across the agency as needed. Client Leadership & Partnership Serve as the senior, trusted client lead for a large pharmaceutical account Build and maintain strong executive-level client relationships Act as a strategic advisor, understanding client business goals and translating them into actionable plans Own overall client satisfaction, engagement quality, and long-term partnership health Strategic & Commercial Ownership Lead account strategy, planning, and prioritization across programs and workstreams Identify growth opportunities within the account and partner with internal teams to scope and deliver them Support commercial conversations including renewals, expansions, and new initiatives Ensure delivery aligns with client expectations, timelines, and budgets Cross-Functional Collaboration Operate as an individual contributor while coordinating closely with internal teams (e.g., medcomms, strategy, operations, analytics, creative, etc.) Pull in subject-matter experts and delivery teams as needed to support client objectives Act as a connector and problem-solver across teams to ensure seamless execution Delivery Oversight Provide senior oversight across programs without direct people management Ensure clarity of scope, quality of outputs, and consistency of execution Proactively identify risks and resolve issues before they escalate Location & Travel Location: Fully remote Travel: Occasional travel to client sites as needed Experience Senior-level experience leading large pharmaceutical or life sciences accounts Strong background in medcomms, agency, consulting, or related client-services environments Proven ability to manage complex, high-stakes client relationships independently Highly strategic thinker with strong commercial instincts Executive presence and credibility with senior client stakeholders Excellent communication, negotiation, and relationship-building skills Comfortable operating autonomously in a fast-moving, ambiguous environment Collaborative mindset with the ability to mobilize teams without formal authority

My client are seeking a Senior Medical Writer to join their global medical communications agency. There are several positions across medical affairs, commercial and publications. Remote opportunities East/West Coast. THE ROLE: Design, develop, and edit a wide range of materials for various audiences Deliver well-written, scientifically accurate materials that align with client objectives and are ready for review. Demonstrate a solid understanding of the brief, asking informed questions to ensure all necessary information is gathered for independent work. Present content updates to clients and collaborate with HCPs and subject matter experts to develop and approve materials. Complete written materials on time and within budget. Utilize client review systems (e.g., Veeva, DataVision) Review basic medical communication deliverables, offering constructive feedback. Confidently attend client meetings and deliverables (e.g., advisory boards) independently, with minimal senior supervision. Develop and maintain in-depth knowledge of relevant therapy areas and products. Conduct research on medical and scientific topics, using reputable sources and annotating them during the writing process. Stay informed about the latest scientific advancements and share relevant knowledge with internal teams and clients. Work flexibly across various client teams, deliverables, and therapeutic areas, gaining expertise in leading experts within specific therapeutic areas Attend and contribute to client meetings, including project kick-offs, status updates, and client/HCP calls as needed. Provide regular updates to senior team members, ensuring they are aware of account activity and flagging any potential issues. Think strategically beyond individual tasks, identifying interdependencies and potential challenges. Follow SOPs and manage time effectively to prioritize across multiple accounts. Consistently meet deadlines, notifying senior team members when additional time is required. Demonstrate an understanding of allocated hours and work efficiently within them. Maintain an average billability of approximately 85%. Ensure timesheets are completed accurately and on time. REQUIRED QUALIFICATIONS: Higher degree in a relevant subject (PhD, MD, PharmD, etc.) Proactive and enthusiastic about trying new things. 2–3 years of medical writing experience within a medical communications agency setting Strong written and verbal communication skills, with a passion for creativity. Good organizational skills and ability to work under pressure. Experience working with clients and HCPs Ability to provide basic reviews of deliverables for scientific accuracy and integrity.

About the Role We are seeking a dynamic and strategic Account Director to join one of our growing pharma advertising partners. This role is ideal for someone with a strong background in healthcare communications who can lead high-profile accounts, foster trusted client partnerships, and drive strategic brand initiatives in a fast-paced, creative environment. As an Account Director, you will serve as the primary client lead, overseeing multi-channel campaigns across HCP, patient, and payer audiences. You’ll partner closely with cross-functional teams—creative, strategy, project management, and medical/scientific—to ensure that client objectives are met with excellence and innovation. Key Responsibilities Client Leadership: Build and maintain strong client relationships, serving as a strategic partner and trusted advisor. Strategic Oversight: Lead the development of brand strategy, positioning, and tactical planning across omnichannel platforms (digital, print, social, experiential, and video). Team Management: Oversee and mentor account teams (Account Managers, Senior Account Executives, Coordinators) to ensure flawless execution and professional growth. Business Growth: Identify opportunities to expand existing client business, drive organic growth, and participate in new business development efforts. Financial Management: Manage budgets, forecasts, and scopes of work to ensure profitability and operational excellence. Collaboration: Partner with internal stakeholders—creative directors, copy/art teams, strategists, and scientific experts—to deliver innovative solutions that drive measurable results. Therapeutic Expertise: Stay current on client therapeutic areas, competitive landscapes, and industry trends to inform client recommendations and agency POVs. Qualifications 7–10+ years of experience in healthcare advertising/communications (agency background required). Proven track record of managing mid-to-large scale pharma accounts (launch experience a plus). Deep understanding of HCP, patient, and payer marketing , including regulatory and compliance nuances (FDA/OPDP familiarity required). Strong leadership skills with experience managing direct reports and cross-functional teams. Excellent communication, presentation, and relationship-building skills. Strategic thinker with demonstrated ability to grow business and deliver innovative solutions. Bachelor’s degree in Marketing, Communications, Business, or related field (MBA a plus).

Product Manager (Senior Staff/Associate Director Level) Hybrid on-site in San Diego, CA About the Role A San Diego-based biotech developing next-generation genomics platforms to transform genetic testing and sequencing is hiring a Product Manager to own the product strategy and commercialization of their target detection platform. This is a hybrid product-and-marketing role: you will translate customer and clinical insight into product requirements and roadmap, build the business case and competitive positioning, and drive go-to-market strategy, launch, and post-launch performance — partnering with engineering, assay, regulatory, and software teams across RUO, LDT, and IVD development phases. Key Responsibilities Own product strategy and roadmap for the company's target detection platform, translating VOC from clinicians, lab directors, and KOLs into prioritized product requirements Partner with engineering, assay development, integration, software, regulatory, and operations to balance clinical value, technical feasibility, and time-to-market Develop product positioning, messaging, and value propositions for clinical, laboratory, and economic buyers — including health-economic and clinical-utility narratives Build business cases and financial models (market sizing, segmentation, ROI) to support executive go/no-go decisions Conduct competitive analysis across sepsis, pathogen identification, and AMR detection to identify differentiation and white-space opportunities Drive GTM strategy with commercial, sales, and marketing leadership — including pricing, channel, and launch-readiness planning Lead product launches end-to-end: sales enablement, collateral, training, KOL engagement, adoption tracking, and post-launch performance Collaborate with regulatory and quality teams to ensure product requirements and commercial materials are compliant in a regulated diagnostics environment Define and track product and commercial success metrics to inform roadmap prioritization Required Qualifications Bachelor's degree in life sciences, biomedical engineering, business, or a related discipline with 8+ years of relevant PM and/or product marketing experience in diagnostics or life sciences. MBA or advanced degree preferred. Demonstrated PM and/or product marketing experience in diagnostics, life sciences, or medical devices — with a track record of bringing products from concept through commercialization Hands-on IVD and LDT development experience, including familiarity with the requirements they impose on product and commercial activities Proven ability to translate VOC and clinical insight into prioritized, actionable product requirements Track record building business cases, financial models, and competitive analyses to inform executive decision-making Experience defining and executing GTM strategy, including positioning, messaging, and value proposition development Strong cross-functional leadership and communication skills across R&D, regulatory, clinical, commercial, and executive stakeholders Self-directed and ownership-oriented — comfortable operating with significant autonomy in an early-stage, evolving environment Preferred Qualifications Direct experience in molecular diagnostics, ideally in sepsis and/or pathogen identification Familiarity with clinical microbiology and infectious disease testing landscapes, workflows, and buyer dynamics Experience developing clinical-utility content, health-economic/ROI models, and KOL and clinical-evidence strategy Experience at an early-stage or scaling diagnostics company balancing near-term delivery against long-term platform strategy Why Join Us Work on cutting-edge genomics and molecular detection technologies Shape the commercial strategy of a differentiated diagnostic platform from the ground up Collaborate with a deeply technical, cross-functional team High visibility and direct impact on product, commercial, and strategic decisions at an early stage

Our global client based in Switzerland is looking for 4 Market Access / Commercialisation consultants to join their global team. The role is working remote with some travel to project sites for initial 6 month contracts. If you are available for a new position and can join in the next 4 weeks please apply. Lead late-stage commercialisation strategy for pharmaceutical/biotech products from Phase 4 clinical trials through to market launch, ensuring alignment between clinical, regulatory, market access, and commercial teams to optimize product positioning and market readiness Develop and execute go-to-market plans including pricing strategy, reimbursement pathways, stakeholder engagement, and launch sequencing across multiple markets, while identifying and mitigating risks that could impact successful commercialisation Provide strategic guidance on real-world evidence generation and Phase 4 study design to support market access, payer negotiations, and post-launch lifecycle management, ensuring clinical data translates into compelling value propositions for healthcare providers and payers Collaborate cross-functionally with medical affairs, marketing, sales, and supply chain teams to ensure operational readiness, establish KPIs for launch success, and implement feedback loops for continuous optimization during the critical launch phase and beyond

Our global client is looking for a Medical Affairs / Patient Affairs consultant to join their team on a three month rolling contract working 2 - 2.5 days a week, the role is fully remote and looking to start in October. Develop and execute comprehensive medical and patient affairs strategies across the product lifecycle, including needs assessments, portfolio strategy development, medical education initiatives, and patient access advocacy programs from early asset through late-stage commercialization Lead strategic cross-stakeholder engagement initiatives including advisory boards, KOL engagement, patient councils, and multi-stakeholder workshops to build relationships and gather insights that inform clinical value propositions and patient-centric materials Create and deliver strategic implementation toolkits, publications, clinical value propositions, and patient access advocacy frameworks that support shared decision-making and integrate patient perspectives into commercial strategies Build organizational capabilities through functional strategy development, capability assessments, strategic planning processes, patient affairs academies, and thought leadership projects while establishing dashboards and KPIs to measure medical and patient affairs performance and competency

Manager / Senior Manager - Strategy Consulting Location: Switzerland (Zurich based) with flexible remote working Level: Manager / Senior Manager Sector: Life Sciences Strategy Consulting The Opportunity A fast-growing boutique life sciences consultancy is building its presence in Switzerland and is hiring a Manager to join a small, high-performing local team. This is a high-ownership role with significant client exposure and the chance to help shape a growing Swiss business—while collaborating closely with an established international team. You’ll lead consulting engagements focused on strategy and operating model topics across the drug lifecycle, partnering with senior stakeholders in global pharma and biotech as well as innovative emerging companies. What You’ll Do Lead client engagements end-to-end: framing problems, guiding analysis, and delivering high-impact recommendations Advise senior stakeholders on asset-level strategy (portfolio/indication thinking, evidence strategy, decision-making frameworks, etc.) Design and support implementation of operating models (structures, governance, processes, cross-functional ways of working) Apply pragmatic change management : stakeholder alignment, impact assessment, adoption planning Manage project delivery: scope, timelines, quality, and day-to-day client relationships Contribute to business development : identifying opportunities, supporting proposals, strengthening local networks in the Swiss life sciences ecosystem Work closely with colleagues across Europe in a collaborative, “one team” model Why This Role Stands Out Build something early-stage in Switzerland with real autonomy and visibility High-impact work spanning medical affairs, clinical development, commercial and cross-functional decision making Direct exposure to senior leaders in global pharma and biotech Boutique culture: quality-first , entrepreneurial, and partnership-led Clear growth path as the firm scales What We’re Looking For Bachelor’s degree in life sciences, pharma sciences, or related (advanced degree preferred : MBA / MSc / MPharm / PhD) Typically 4+ years’ experience in life sciences consulting , strategy consulting, or within pharma/biotech (relevant in-house experience welcomed) Strong understanding of asset strategy and the pharma value chain Hands-on experience with operating model design and implementation (org structures, governance, processes, cross-functional working) Comfortable leading projects/workstreams with accountability for delivery and client management Highly analytical, structured problem-solver who thrives in ambiguity Confident communicator (written and verbal), able to influence senior stakeholders MS Office proficiency (PowerPoint/Excel/Word/Outlook) Fluent English required ; German a plus Must be eligible to work in Switzerland

Overview A high-growth, global life sciences manufacturing organisation is seeking an experienced Quality Manager to lead and evolve its site-wide Quality function. This is a pivotal leadership role responsible for shaping and scaling the Quality Management System (QMS) , ensuring regulatory compliance, and driving continuous improvement across manufacturing operations. You will play a key role in enabling operational excellence, supporting global customers, and ensuring the organisation is positioned to scale effectively. Key Responsibilities Own and lead the site Quality Management System (QMS) , ensuring alignment with internal, customer, and regulatory requirements Manage and oversee internal and external audits , ensuring robust compliance and continuous improvement Lead the investigation and resolution of non-conformances, deviations, and customer complaints , including CAPA management Oversee quality events and manufacturing excursions , ensuring root cause, impact, and corrective actions are clearly defined and executed Provide regular reporting to senior leadership on QMS performance, KPIs, and improvement opportunities Lead supplier quality and risk management , including audits and performance monitoring Develop and maintain Quality Control (QC) processes , ensuring product and material compliance Drive process improvement initiatives (Lean / Six Sigma / validation-led improvements) to enhance quality and efficiency Build, lead, and develop a high-performing quality team , including hiring, training, and capability development Experience & Requirements Strong experience operating within regulated manufacturing environments (pharma, biotech, or medical devices) Deep understanding of ISO standards (9001 / 13485) and cGMP requirements Proven experience managing CAPA systems, audits, and quality investigations Experience implementing or maintaining Quality Management Systems (QMS) Strong knowledge of risk management, validation, and process control methodologies Experience working with suppliers and outsourced manufacturing partners Ability to apply data-driven and statistical approaches to quality and operational challenges Excellent communication and stakeholder management skills, including presenting to senior leadership Preferred Knowledge of global regulatory frameworks (e.g. FDA, EU regulations) Exposure to 21 CFR Parts 210/211 and/or 820 Lean / Six Sigma certification or equivalent experience Strong leadership experience within a growing or scaling organisation Education Bachelor’s degree in Life Sciences, Engineering, or related field Typically 5+ years’ experience in Quality within a regulated manufacturing environment Why This Role Opportunity to lead Quality within a scaling, high-impact life sciences organisation Direct influence on operational performance, compliance, and customer outcomes Visibility with senior leadership and ability to shape quality strategy at site level

We are currently looking for a Senior CAPEX Project Manager responsible for leading the end-to-end delivery of complex capital investment projects within regulated pharmaceutical manufacturing environments. Accountable for delivering projects safely, on time, within budget, and in compliance with GMP and corporate standards. The role includes leadership of external manufacturing and EPC/EPCM delivery partners across multi-disciplinary global teams. Key Responsibilities Lead full project lifecycle delivery from feasibility and business case development through design, construction, commissioning, qualification, and operational handover. Manage medium to large-scale pharmaceutical manufacturing and infrastructure capital projects, including cleanrooms, utilities, and production facilities. Oversee external contractors, suppliers, and EPC/EPCM partners to ensure alignment with safety, quality, cost, and schedule objectives. Develop and maintain project execution plans, budgets, schedules, governance frameworks, and risk management strategies. Ensure compliance with cGMP, GxP, EHS, validation, and corporate engineering standards throughout project execution. Coordinate cross-functional teams across Engineering, Validation, Quality, Operations, Procurement, Supply Chain, and Finance. Drive project controls including cost management, forecasting, change control, and mitigation of project risks. Lead project stage-gate reviews and provide clear reporting to senior leadership and investment governance stakeholders. Support regulatory inspections, audits, and strategic manufacturing network initiatives. Champion strong health, safety, and environmental performance across all project activities. Qualifications & Experience Bachelor’s degree in Engineering (Chemical, Mechanical, Process, or related discipline); advanced degree preferred. 15+ years of capital project delivery experience within pharmaceutical, biotechnology, or regulated life sciences environments. Proven experience delivering large-scale capital projects, including programmes exceeding $25M. Strong knowledge of pharmaceutical GMP manufacturing, cleanroom design, utilities, and validation principles. Demonstrated leadership of large, cross-functional, and international project teams. Extensive experience managing EPC/EPCM contractors and complex supply chains. Advanced project management expertise in scheduling, budgeting, governance, and risk management. Strong stakeholder engagement, communication, and executive reporting skills. PMP, PRINCE2, or equivalent project management certification preferred.

We are currently looking for a Senior Design Engineer for a leading biotechnology company in Nottinghamshire or Luxembourg. This position is a full-time, permanent position, and the successful candidate will be reporting to the Director of Design Engineering. Key Responsibilities Translate customer requirements into clear, accurate, and manufacturable engineering drawings and technical documentation Create and maintain 2D/3D CAD models and assemblies using SolidWorks Act as a key interface between customers, sales, and manufacturing teams to ensure design requirements are understood and executed Support Design for Manufacturing (DFM) activities and drive improvements in drawing quality, standardisation, and engineering processes Manage Bills of Materials (BOMs), engineering change requests, and documentation within PLM/ERP systems Participate in design reviews and contribute to continuous improvement initiatives across engineering and manufacturing . Requirements Bachelor's degree in Mechanical Engineering, Bioengineering, or a related discipline 10+ years' experience in design engineering or drafting within a regulated manufacturing environment Advanced SolidWorks experience, including part modelling, assemblies, and technical drawing creation Strong knowledge of GD&T, tolerance analysis, and engineering drawing standards (ASME/ISO) Experience working with BOMs, engineering change processes, and PLM/ERP systems Background in medical devices, bioprocessing, or other highly regulated industries preferred Strong communication skills with experience collaborating across customer-facing and cross-functional teams Ability to work independently in a fast-paced, high-volume environment

BioTalent are partnered with a fast-growing Biopharma CDMO to seek an experienced Director/Senior Director of Project Management to lead and strengthen biopharmaceutical project delivery capability. This is a senior leadership role with accountability for end-to-end project execution, client engagement, and the ongoing development of a robust, scalable project management framework within a CDMO environment. Key Responsibilities Project Planning & Delivery Develop comprehensive project plans and implementation schedules aligned to client requirements, internal technical capabilities, and production realities. Define clear project objectives, task ownership, timelines, and resource requirements. Drive disciplined project execution, tracking progress in real time and ensuring projects are delivered on schedule. Project Oversight & Risk Management Lead regular project governance meetings and status reviews. Identify, escalate, and resolve risks and issues promptly to minimise impact on timelines, quality, and cost. Manage change control throughout the project lifecycle. Cross‑Functional Coordination Act as the central coordination point across R&D, Manufacturing, Quality, and Supply Chain. Ensure timely availability of people, equipment, and materials to support successful project execution. Client & Partner Engagement Maintain close, professional relationships with clients and external partners. Provide clear, timely communication on project progress and key milestones. Manage client expectations and respond effectively to evolving project requirements. Project Management Systems & Process Development Establish, standardise, and continuously improve the biopharmaceutical project management framework. Develop and implement project management processes, standards, and governance models to enhance consistency, transparency, and professionalism across the organisation. Team Leadership & Development Build, lead, and develop a high‑performing project management team. Implement training, performance evaluation, and development plans to strengthen technical and leadership capability. Qualifications & Experience Master’s degree or higher in Biochemistry, Molecular Biology, Cell Biology, Immunology, Pharmacy, or a related discipline. Exceptional candidates with a Bachelor’s degree may be considered. Significant project management experience within a biopharmaceutical CDMO environment. Strong knowledge of global regulatory requirements and guidelines (GMP, ICH, FDA, EMA); experience supporting regulatory submissions and GMP inspections is highly advantageous. Fluent in both English and Mandarin , with the ability to conduct technical and commercial discussions and produce project documentation in English. Willingness to relocate to and be based in Shanghai. (Relocation support is available.) Reach out to greg.hammond@biotalent.com for more information.

Site Director, Clinical Research Greater Boston Area, Massachusetts – Onsite A growing clinical research organization is seeking a Site Director to lead site operations, staff development, compliance initiatives, and clinical trial execution within a fast-paced research environment. Responsibilities: Lead and develop Clinical Research Coordinators, Research Assistants, and other site personnel Oversee day-to-day clinical trial operations, enrollment activities, study conduct, and site performance Ensure compliance with GCP, FDA regulations, study protocols, and quality standards Drive operational excellence through process improvement, problem-solving, and risk mitigation Partner with internal stakeholders to support staffing, resource planning, budgets, and study execution Serve as a key point of contact for sponsors, monitors, and external partners Support audits, inspections, quality initiatives, and corrective action planning Qualifications: Bachelor's degree required 5+ years of clinical research experience 4+ years of people management experience Strong understanding of GCP, FDA regulations, and clinical trial operations Proven leadership, communication, and organizational skills Experience managing complex operational challenges in a clinical research environment Research site leadership experience is required Sponsored trial experience is required

Nurse Practitioner or Physician Assistant Dallas, Texas | Onsite | Full Time Position Overview A growing clinical research organization is seeking a full-time, onsite Psychiatric Nurse Practitioner or Physician Assistant in Dallas. The role combines Sub-Investigator medical support with clinical rating responsibilities, supporting physician investigators and conducting standardized psychiatric and neurologic assessments for sponsored clinical trials. Ideal for a licensed NP or PA with psychiatric or neurologic patient care experience who is interested in clinical research. Prior research experience is preferred but not required. Key Responsibilities Conduct protocol-required physical, neurological, and psychiatric assessments Review labs, ECGs, adverse events, and concomitant medications Perform standardized clinical interviews and rating scales Monitor participant safety, protocol compliance, and data quality Collaborate with investigators and the research team Follow GCP and regulatory requirements Qualifications Active NP or PA license in good standing Psychiatry, neurology, or behavioral health experience Experience with psychiatric and/or neurologic patients preferred Comfortable performing physical exams and reviewing labs/ECGs Clinical research or standardized psychiatric assessment experience is a plus

EMEA Sales Associate Director | Drug Product Services Join a leading global CDMO and play a key role in driving growth across the EMEA region. We're looking for a commercially sharp, results-driven sales professional with a proven track record in aseptic fill-finish services and biologics manufacturing. What You'll Do Win new business and expand strategic customer relationships across EMEA. Drive sales of aseptic fill-finish solutions, including liquid vials, lyophilised vials, cartridges, and pre-filled syringes (PFS) . Build influential relationships with stakeholders from technical teams to C-suite executives. Identify, develop, and close high-value opportunities within biotech and pharmaceutical accounts. Shape territory strategy through market intelligence, customer insights, and competitive analysis. Partner with cross-functional teams to deliver winning customer solutions. What You'll Bring 5+ years' commercial experience within pharma, biotech, or CDMO environments. Demonstrated success selling aseptic fill-finish and sterile manufacturing services . Experience working with customers ranging from emerging biotech companies to global pharmaceutical organisations. Strong commercial acumen, negotiation skills, and stakeholder management capability. Life Sciences degree or equivalent industry experience. Fluent English; additional European languages are advantageous. Why This Role? This is a high-impact opportunity for an ambitious sales person who understands the fill-finish market, thrives on winning new business, and wants to influence growth within a globally recognised organisation.

AI Research Scientist – Biological Foundation Models 📍 Paris (hybrid) | 💰 €80,000–€100,000 + equity We’re partnering with an innovative deeptech company at the forefront of AI-driven drug discovery in immunology . Their mission is to tackle one of the biggest challenges in pharma R&D — bridging the gap between preclinical research and clinical success using cutting-edge foundation models. This is a unique opportunity to work on large-scale, multimodal biological data and contribute to a next-generation AI platform designed to predict patient outcomes and accelerate therapeutic development. The Role As an AI Research Scientist , you will design, train, and scale deep learning models applied to complex biological systems. You’ll work on multimodal transformer architectures across transcriptomics, histology, and clinical data — pushing the boundaries of biological foundation models. You’ll collaborate closely with a multidisciplinary team of ML researchers, computational biologists, and immunologists, translating model outputs into real-world impact across drug discovery and development. What You’ll Be Doing Design and train transformer-based foundation models on large-scale biological datasets Develop pre-training and fine-tuning strategies across species, tissues, and diseases Work on multimodal learning (omics, imaging, clinical data) Run scaling experiments and optimise model performance Contribute to and lead publications in top-tier ML and computational biology venues Apply models to real-world challenges: target validation, biomarker discovery, and patient stratification What We’re Looking For PhD in Machine Learning, Computer Science, Applied Mathematics, or similar 3+ years’ experience in deep learning research Strong publication record (e.g. NeurIPS, ICML, ICLR, AAAI) Expert Python skills with PyTorch experience Experience training models on large-scale datasets Nice to Have Experience with biological or multi-omics data Background in foundation models, self-supervised or multimodal learning Experience training large-scale models (>300M parameters) Comfortable working in fast-paced, high-growth environments If you’re excited about applying cutting-edge AI to solve real-world biological problems, this is a rare opportunity to make a tangible impact in drug discovery. Feel free to reach out for more details or a confidential discussion.

Director/Senior Director, Clinical Development Location: New Jersey Employment Type: Full-Time Function: Clinical Development Position Overview A clinical-stage biopharmaceutical company is seeking an experienced Director or Senior Director of Clinical Development to provide medical and scientific leadership across its oncology portfolio. This individual will lead the strategy, design, execution, and interpretation of clinical trials while collaborating with cross-functional teams to generate high-quality clinical data supporting product development, regulatory submissions, and broader business objectives. Key Responsibilities Lead the design and execution of clinical development programs based on medical, scientific, regulatory, and commercial objectives. Provide strategic medical input throughout the product lifecycle, from early clinical development through Phase 3. Oversee the medical integrity, quality, and execution of clinical trials. Partner with Clinical Operations to support patient enrollment, study timelines, and key development milestones. Monitor clinical safety in collaboration with Pharmacovigilance and Safety teams, including oversight of serious adverse event reporting. Lead or contribute to clinical documents, including protocols, Investigator’s Brochures, Clinical Study Reports, regulatory submissions, and health authority response packages. Serve as the medical lead for cross-functional clinical study teams. Represent Clinical Development during regulatory interactions and external scientific discussions. Ensure compliance with GCP, pharmacovigilance requirements, internal procedures, and applicable global regulations. Provide clinical expertise for assigned compounds and oncology indications. Build relationships with investigators, external experts, and key opinion leaders to inform clinical strategy and protocol development. Maintain current knowledge of oncology research, clinical practice, competitive developments, and evolving regulatory expectations. Qualifications M.D. or equivalent medical degree. International medical degrees will be considered. At least two years of medical monitoring experience supporting oncology clinical trials. Phase 1 and Phase 2 oncology experience required. Phase 3 experience preferred. Previous experience within a biotechnology or pharmaceutical clinical development organization. Demonstrated experience overseeing clinical trial safety and interpreting medical and safety data. Experience supporting the development of biologic oncology therapies, including antibody-based or immuno-oncology programs, strongly preferred.

Associate Director Operational Excellence Be part of our team We are seeking a highly experienced Associate Director of Operational Excellence (GCP) to lead continuous improvement efforts across our clinical trial operations and ensure adherence to the highest standards of GCP compliance. The position will be within the Quality Assurance (QA) department. We are a dedicated QA team supporting our development of antibody-drug conjugates (ADCs) and clinical trials with a strong focus on reliable processes and patient safety. Working closely together, we ensure that quality and compliance are part of every step, from research to clinical application. Our team values open communication, practical problem-solving, and a shared responsibility for doing things right. If you enjoy working in a supportive environment where your contributions make a real difference, we’d be happy to hear from you. Your mission Lead strategic initiatives to optimize clinical trial processes and drive operational efficiency across GCP-regulated activities. Establish and maintain GCP-compliant process frameworks tailored to early-phase oncology trials. Collaborate with cross-functional teams (e.g., Clinical Operations, Clinical Development, QA, Project Management) to identify process weaknesses, bottlenecks and implement process improvements. Conduct gap analyses to identify potential business process and / or systems deficiencies Draft new SOPs and revise existing documents to reflect optimized, compliant and scalable practices Facilitate SOP review cycles, incorporating stakeholder feedback and ensuring alignment with internal policies and applicable regulatory requirements Analyze operational data and performance metrics to drive data-informed decision making and promote accountability. Champion risk-based approaches in clinical operations, including proactive risk identification, mitigation planning, and CAPA oversight. Support inspection readiness activities and serve in close collaboration with QA and the operational teams as a key contributor in internal audits and regulatory inspections. Your profile Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field Minimum of 10 years of experience in clinical research, with at least 5 years in an operational excellence, quality, or process improvement role. Extensive expertise in crafting process documents and translating the requirements of operational departments into practical, streamlined, and compliant process descriptions. In-depth knowledge of ICH-GCP and regulatory requirements relevant to oncology trials. Strong analytical skills with a demonstrated ability to translate data into operational insights. Proven success in leading cross-functional improvement initiatives in a fast-paced biotech or start-up environment. Excellent communication and facilitation skills; ability to influence without authority Fluent in English, oral and written communication Must have worked in a biotech ideally start-up environment Experience with authority inspections (FDA, EMA, MHRA) Why us? Flat hierarchies and short decision-making processes; open corporate culture; possibility of mobile working; unlimited contract after probationary period; 30 days' vacation; strong team spirit; personal appreciation of values; multicultural and global team and high level of collegiality; regular team events; mobility allowance; pleasant office atmosphere, modern technology standard. About us The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and antibody-drug conjugates (ADCs). With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.Associate Director Operational Excellence Be part of our team We are seeking a highly experienced Associate Director of Operational Excellence (GCP) to lead continuous improvement efforts across our clinical trial operations and ensure adherence to the highest standards of GCP compliance. The position will be within the Quality Assurance (QA) department. We are a dedicated QA team supporting our development of antibody-drug conjugates (ADCs) and clinical trials with a strong focus on reliable processes and patient safety. Working closely together, we ensure that quality and compliance are part of every step, from research to clinical application. Our team values open communication, practical problem-solving, and a shared responsibility for doing things right. If you enjoy working in a supportive environment where your contributions make a real difference, we’d be happy to hear from you. Your mission Lead strategic initiatives to optimize clinical trial processes and drive operational efficiency across GCP-regulated activities. Establish and maintain GCP-compliant process frameworks tailored to early-phase oncology trials. Collaborate with cross-functional teams (e.g., Clinical Operations, Clinical Development, QA, Project Management) to identify process weaknesses, bottlenecks and implement process improvements. Conduct gap analyses to identify potential business process and / or systems deficiencies Draft new SOPs and revise existing documents to reflect optimized, compliant and scalable practices Facilitate SOP review cycles, incorporating stakeholder feedback and ensuring alignment with internal policies and applicable regulatory requirements Analyze operational data and performance metrics to drive data-informed decision making and promote accountability. Champion risk-based approaches in clinical operations, including proactive risk identification, mitigation planning, and CAPA oversight. Support inspection readiness activities and serve in close collaboration with QA and the operational teams as a key contributor in internal audits and regulatory inspections. Your profile Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field Minimum of 10 years of experience in clinical research, with at least 5 years in an operational excellence, quality, or process improvement role. Extensive expertise in crafting process documents and translating the requirements of operational departments into practical, streamlined, and compliant process descriptions. In-depth knowledge of ICH-GCP and regulatory requirements relevant to oncology trials. Strong analytical skills with a demonstrated ability to translate data into operational insights. Proven success in leading cross-functional improvement initiatives in a fast-paced biotech or start-up environment. Excellent communication and facilitation skills; ability to influence without authority Fluent in English, oral and written communication Must have worked in a biotech ideally start-up environment Experience with authority inspections (FDA, EMA, MHRA) Why us? Flat hierarchies and short decision-making processes; open corporate culture; possibility of mobile working; unlimited contract after probationary period; 30 days' vacation; strong team spirit; personal appreciation of values; multicultural and global team and high level of collegiality; regular team events; mobility allowance; pleasant office atmosphere, modern technology standard. About us The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and antibody-drug conjugates (ADCs). With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.

Director, Program Management Germany About Tubulis Tubulis is dedicated to developing novel, effective, and safe therapies for the treatment of cancer — one of the most pressing challenges in modern medicine. Our mission is to become a leading company in targeted therapeutics and antibody–drug conjugates (ADCs). With a passionate team, proprietary technologies, and innovative therapeutic concepts, we are ushering in a new era in the fight against cancer. Join a multidisciplinary, highly focused group working to deliver promising ADCs to patients with solid and haematological cancers. Position Overview We are seeking a proactive and committed Director, Program Management to provide strategic leadership and operational excellence for TUB-040, Tubulis’ lead program, as well as for our portfolio of innovative therapeutic programs spanning early- and late-stage clinical development. The Director will partner closely with leaders in Clinical Development, Regulatory, CMC, Biomarkers, PK, Nonclinical, Commercial, and other functions to ensure timely delivery of key milestones, robust risk management, and smooth progression of programs toward regulatory approval and commercialization. The role reports to the Vice President, Program Management . Key Responsibilities Lead the cross-functional TUB-040 program team through all stages of clinical development — from IND-enabling studies to pivotal trials and regulatory submissions. Serve as the primary point of contact for program strategy, planning, execution, and milestone delivery. Develop and maintain integrated program plans, budgets, timelines, and risk management strategies aligned with corporate objectives. Partner with functional leaders (Clinical Development, Clinical Operations, Regulatory, CMC, Biostatistics, Biomarkers, Commercial, etc.) to ensure requirements are well-defined, resourced, and executed with quality. Drive effective decision-making by preparing clear program updates and recommendations for governance committees. Provide mentorship within the Program Management function, fostering process improvements and building organizational capabilities. Encourage collaboration, guide team members, address challenges, and promote a positive working environment. Maintain open communication with the VP Program Management, team members, partners, and key stakeholders. Candidate Profile Bachelor’s or advanced degree in a relevant scientific discipline. 10+ years of experience in the biotechnology or pharmaceutical industry, with significant program/project management leadership. Demonstrated success advancing programs through multiple phases of clinical development (IND/CTA, Phase I–III, BLA/MAA, launch, lifecycle management). Proven expertise in late-stage development and pivotal trials. Comprehensive knowledge of clinical development, regulatory requirements, GxP, CMC, nonclinical, and commercialization aspects. Strong leadership, organizational, and interpersonal skills with the ability to inspire and motivate cross-functional teams. Excellent communication and presentation skills; able to synthesize complex data and present compelling updates to leadership and stakeholders. Proficiency with project management tools (MS Project, Excel, PowerPoint, Think-Cell). Self-starter with strong problem-solving skills; comfortable working in a fast-paced, dynamic environment. Fluent English (written and spoken); German is a plus. Why Join Us Flat hierarchies and short decision-making processes. Open corporate culture with mobile working options. Unlimited contract following probation, plus 30 days of vacation. Mobility allowance, modern technology, and a pleasant office environment. Strong team spirit, appreciation of individual contributions, and regular team events. Work alongside a multicultural, global team passionate about advancing next-generation cancer therapies.

Manager QA GCP/GLP About Tubulis At Tubulis , we are shaping a new generation of antibody-drug conjugates (ADCs) designed to bring safer, more effective treatments to patients with cancer. By combining proprietary conjugation technologies with deep expertise in biologics, we create targeted therapeutics that unlock the full potential of ADCs. Join a passionate, multidisciplinary team committed to excellence, innovation, and improving patient outcomes worldwide. About the Role We are seeking an experienced Manager QA GCP/GLP to join our Quality Assurance team. In this role, you will support the development of our innovative ADC pipeline and clinical programs, ensuring compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and all relevant regulations. Working closely with internal stakeholders and external partners, you will drive quality standards across research, development, and clinical activities. Key Responsibilities Design and maintain a global GCP audit program in collaboration with the Director, QA–GCP. Manage vendor qualification programs for assigned suppliers and service providers. Plan, execute, and deliver audits in the GCP area (all clinical phases, suppliers, systems, and documentation) to assess compliance with Tubulis SOPs and international regulations (ICH, CTR, FDA, EMA, national). Oversee audit activities for GLP vendors and review/approve GLP quality documentation provided by suppliers. Act as a subject matter expert, offering GxP guidance and interpreting regulations to identify risks, trends, and improvement opportunities. Represent QA in internal forums, including Tubulis trial team meetings, as assigned. Act as the QA counterpart for GCP/GLP vendors, addressing and resolving quality-related issues. Support regulatory inspections (preparation, hosting, and follow-up). Contribute to the development and maintenance of the Quality Management System (QMS) for GCP/GLP in collaboration with the Director, QA–GCP. Your Profile Bachelor’s or Master’s degree in a Life Sciences or Medical discipline. Minimum 5 years’ experience in Quality Assurance for GCP within the biotech or pharmaceutical industry. Proven experience auditing GCP vendors, including CROs, laboratories, and clinical trial sites. Experience auditing or overseeing audits of GLP vendors is an advantage. Fluent English (written and spoken). Strong knowledge of international GCP and GLP regulations and guidelines (EU, MHRA, FDA), or a willingness to develop GLP expertise. Excellent communication, problem-solving, and stakeholder management skills. Why Join Us Flat hierarchies and quick decision-making in an open, collaborative culture. Flexible working options, including mobile working. Unlimited contract after probation, with 30 days’ vacation. Competitive compensation and mobility allowance. A supportive, multicultural team with a strong sense of collegiality. Regular team events and a modern working environment. Be part of our mission to deliver breakthrough ADC therapies to patients worldwide.