Engineering and CQV

JOB DESCRIPTION Title: Global Sr. Regulatory Compliance Specialist Department: Quality Reports To: Chief Quality Officer FLSA Status: Exempt Job Summary The Senior Regulatory Compliance Specialist is responsible for ensuring that our products and technical files align with applicable regulatory requirements, including global pharmacopeias, relevant standards and testing requirements. This role supports customer inquiries, customer regulatory submissions, and monitors ongoing compliance with the standards upon which the company certifies to and will maintain and update product technical files and monitor relevant standards and pharmacopeias to ensure that upcoming changes/revisions are communicated and implemented. Essential Functions Ensure product compliance with: USP EP Other applicable global regulations/standards Monitor regulatory updates applicable to our products and assess impact on company procedures and products. Identify and support implementation of new or revised regulatory requirements. Provide recommendations for robust testing plans to ensure compliance Based on upcoming and revised regulatory changes. Review, communicate and remediate gaps in partnership with Product Line Management and Engineering for our product technical files. Perform additional job duties as assigned. Education / Certifications Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field Required Experience & Competencies Minimum 4 to 7 years of experience in pharmaceutical regulatory compliance or quality assurance. Direct experience in reviewing/interpreting USP/EP/regulatory standards and recommending/communicating implementation plans. Hands-on ownership of product technical files and regulatory documentation throughout product lifecycle. Experience monitoring regulatory updates and implementing compliance changes across product portfolios. Technical file creation and revision experience required. Strong understanding of cGMP documentation requirements. Excellent written and verbal communication skills. Travel required up to 10%

Summary We have an immediate opening for a Senior Quality Specialist. This highly visible position is responsible for meeting and exceeding goals by advancing high-quality spinal fusion solutions utilizing cutting-edge implant technology. This role supports the operations organization with day-to-day, near-term, and long-term execution of quality tasks, requiring strong interpersonal skills and the ability to quickly meet supply chain requirements while supporting customer service, sales, engineering, and operations departments. Responsibilities Route, release, and control quality system documents Assign, monitor, and retain training records Maintain supplier qualification status Support the audit program and supplier quality activities Create and manage the CAPA and complaint program Lead nonconforming material investigations and segregation activities Support Quality Management Review Conduct DMR review for incoming and outgoing inspection Support development and maintenance of quality plans Requirements Bachelor's degree 3+ years of medical device experience Proficiency in Microsoft Office suite (Outlook, Excel, Word, PowerPoint, etc.) Ability to thrive in a startup environment Experience with an orthopedic medical device company or spine experience a plus ISO 13485 QMS auditor certificate

Summary We have an immediate opening for a Senior R&D Engineer. This highly visible position is responsible for the development and design of medical device instruments and implants, with quality and engineering development goals assigned to advance our high-quality spinal solutions using cutting-edge implant and instrument technology. This role requires strong mechanical design skills spanning brainstorming, design, prototyping support, DFM support, regulatory support, and product launch support, along with hands-on medical device design experience using SolidWorks and a solid understanding of medical device design controls. Responsibilities Lead design and development activities to release new product lines and maintain current ones Support marketing, quality, and regulatory departments as needed Mentor associate engineers and engineering interns as needed Requirements B.S. in Engineering, Mechanical or Biomechanical Minimum 5 years of related work experience (spine experience preferred) Proficiency in Microsoft Office suite (Outlook, Excel, Word, PowerPoint, etc.) Experience with an orthopedic medical device company or spine experience a plus Ability to multi-task and thrive in a startup environment 3+ years of experience with SolidWorks design software

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.

Director of Procurement — Medical Device Location: Irvine, California or Remote Travel: Up to 30% Summary of Role We're a scaling medical device company seeking a Director of Procurement to lead our procurement team and provide strategic oversight of all sourcing, supplier management, and contract manufacturing (CMO) operations. This is an operationally focused leadership role responsible for stabilizing and maturing our procurement processes, strengthening supplier capabilities, and building a scalable global procurement strategy aligned with our commercialization goals and compliance requirements. Responsibilities Lead, mentor, and develop a team of six buyers across direct, indirect, and NPI procurement categories Strengthen sourcing strategies for components, materials, tooling, and services Own the full supplier lifecycle — selection, qualification, onboarding, and ongoing performance management Negotiate contracts, pricing, and commercial terms to achieve cost, quality, and risk-mitigation goals Serve as the primary operational interface for external manufacturing partners in Germany and other global regions Oversee capacity planning, production scheduling, and issue resolution with CMOs Support technology transfer, scale-up, and validation activities in collaboration with Engineering and Quality Establish and maintain supplier governance frameworks, KPIs, and performance review mechanisms Ensure supplier compliance with ISO 13485, EU MDR, FDA QSR, and internal quality requirements Lead supplier audits, corrective actions, and risk-mitigation initiatives Maintain supplier risk assessments and business continuity plans Partner cross-functionally with Engineering, Quality, Regulatory, and Finance to align procurement strategy with product development and commercialization milestones Support ERP, MRP, and master data initiatives related to suppliers, materials, and BOM accuracy Deliver regular reporting on procurement KPIs, supplier health, cost performance, and risk exposure Participate in and contribute to S&OP and broader company strategic goals Requirements Bachelor's degree in Supply Chain, Engineering, Business, or a related field 6–10 years of procurement and supplier management experience in MedTech, preferably with Class III Cardiovascular or Neurovascular experience Demonstrated experience managing CMOs and leading cross-functional sourcing initiatives Working knowledge of EU MDR, ISO 13485, and FDA QSR regulations Experience working in a startup or high-growth environment preferred Strong negotiation capabilities with a track record of managing complex supplier relationships preferred Proficiency with ERP systems, procurement tools, and data-driven decision-making preferred

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)

Manufacturing Engineering Manager | Irvine, CA (Onsite) You'll lead and manage precision CNC machining and assembly operations while driving cost reduction, process improvement, and the transfer of new product development into full production. Responsibilities: Provide people leadership and technical direction to a team of 9 across Manufacturing Engineers and Machinists Oversee precision CNC machining operations, including manual machine shop equipment and assembly line processes Lead NPD-to-production transfer, taking new products through first-time production launch Drive cost reduction and process improvement initiatives across manufacturing operations Manage day-to-day priorities, mentorship, and performance across the manufacturing engineering team Partner cross-functionally with Quality, Engineering, and Operations to resolve production and process issues Support production readiness and scalability across machine shop and assembly line environments Required Experience: B.S. Degree or higher with 7+ years of relevant experience in Manufacturing Engineering 4+ years of people-management experience Strong background in precision CNC machining Experience in a regulated manufacturing environment; medical device experience preferred Proven people management experience — this role carries more direct leadership responsibility than a typical IC-level engineering role Hands-on oversight experience across both machine shop and assembly line operations Direct experience leading cost reduction and process improvement projects Track record of transferring new product designs into production for the first time Logistics Fully onsite in Irvine, CA Salary: $165K–$175K

R&D Manager — Orthopedic Summary We're looking for an R&D Manager to lead the design and development of orthopedic and powered surgical medical devices, from concept through commercialization. You'll provide technical, functional, and people leadership to an engineering team, driving cross-functional product development with Manufacturing, Quality, Regulatory, Supply Chain, and Business Development. This role ensures compliance with design controls, manufacturability, and regulatory requirements while optimizing product performance, reliability, cost, and scalability. The ideal candidate has hands-on experience developing powered electromechanical surgical devices — surgical handpieces, drills, drivers, reamers, saws, robotic end effectors, or similar orthopedic instrumentation — along with a proven track record leading engineering teams and bringing medical devices to market in a regulated environment. Responsibilities Lead design and development activities from customer requirements through proof of concept, verification/validation, and commercialization Provide technical leadership and direction to engineers and designers, including mentoring, work prioritization, and performance guidance Own product development programs, including timelines, deliverables, and cross-functional alignment with Manufacturing, QA/RA, Supply Chain, and Business Development Ensure compliance with design control requirements, including Design History Files (DHF) and Technical Files; review and approve engineering designs, drawings, specifications, and test protocols Drive Design for Manufacturability, Inspection, and Assembly (DFMIA) to support efficient, scalable production Evaluate and resolve complex design and process issues impacting product performance, manufacturing, inspection, or assembly Lead tolerance analysis, risk assessments, and design reviews Collaborate with internal teams and external suppliers to support development, troubleshoot issues, and optimize designs Oversee verification and validation activities, including test method, protocol, and report development Gather and analyze data related to manufacturing processes, costs, materials, and methods to support decision-making Participate in or lead customer interactions related to product development initiatives Lead or participate in continuous improvement initiatives related to engineering processes and product development Requirements Bachelor's degree in Mechanical Engineering, Electrical Engineering, or related field required; advanced engineering degree a plus 7+ years of relevant industry experience in product design and development (5-10 years as a Design Engineer within medical devices) Prior leadership or supervisory experience strongly preferred Experience in regulated industries required, preferably medical device, with working knowledge of IEC 60601-x, ISO 13485, and FDA 21 CFR Part 820 Strong experience with design controls and DHF requirements; ISO 14971 risk management experience preferred Proficiency in 3D CAD software (SolidWorks preferred) Strong background in electromechanical product design and development; CNC machining and manufacturing process experience preferred Strong understanding of Design for Manufacturability, Inspection, and Assembly (DFMIA) Advanced knowledge of ASME Y14.5 GD&T and engineering drawing standards; ability to perform tolerance stack-up analysis Strong analytical and problem-solving skills with a data-driven approach

We're looking for a Director of Clinical Research to own our clinical research organization — the data collection and scientific backbone of the company. You'll lead a team of 10+ research associates, data scientists, and data engineers, and serve as the senior physiological authority across every human research study powering our hardware, sensing, and AI/ML teams. You'll also own program management across the clinical team's full breadth — hardware studies, AI/ML development studies, and women's sleep studies — while acting as our public-facing voice on the science of sleep, from peer-reviewed publications to press and podcast appearances. This is a hands-on leadership role: you'll be as comfortable defining statistical criteria and reviewing raw data as you are managing people, budgets, and cross-functional stakeholders. What You'll Do Own the clinical research & science organization — lead, mentor, and grow a team of 10+ spanning clinical operations, data engineering, and data science Direct all human research studies supporting Hardware, Sensing, and AI/ML teams, from protocol development and study ideation through IRB submission, data collection, analysis, and reporting Uphold scientific validation standards by applying rigorous statistical and testing criteria (e.g., MAE, TOST equivalence testing, Bland-Altman analysis) to evaluate hardware and algorithm performance before launch Translate research into product features by partnering with Product, Growth, Design, and Engineering teams on science-backed features Provide scientific input on marketing claims, press releases, and journalist articles, ensuring every public-facing claim is backed by data Lead scientific communications — author and direct blog posts, white papers, and peer-reviewed publications, and represent the company in press interviews, podcasts, and conference talks Manage team growth and performance, including hiring, compensation strategy, mentorship, and formal performance management Drive new research exploration, identifying and pursuing external collaborations and new areas of sleep science Own budget and vendor management for clinical studies What You Bring PhD in physiology, neuroscience, sleep science, or a related field 10+ years of human research experience, including at least 5 years at high-growth startups or consumer health/hardware technology companies 5+ years of people management experience, including hiring, compensation decisions, and formal performance management Experience with biosensing devices or consumer health technology pursuing clinical validation Strong record of peer-reviewed publications; experience as author or Principal Investigator on IRB-approved clinical studies Advanced statistical fluency — able to define statistical criteria, run power calculations, and work directly with raw data alongside data scientists and biostatisticians Experience managing cross-functional programs spanning hardware validation, sensing, AI/ML, product, and marketing Excellent written and verbal communication skills across scientific and consumer audiences Hands-on, execution-oriented mindset, comfortable owning studies end-to-end in a fast-moving environment

Principal Optical Engineer | San Diego, CA (Onsite) We're hiring a Principal Optical Engineer to own the optical architecture of a next-generation DNA sequencing platform — from concept through commercialization. You'll drive the design, simulation, tolerancing, and characterization of a high-sensitivity optical detection system, partnering closely with cross-functional and external CRO/CDMO teams to bring a manufacturable product to market. What You'll Do Define optical architecture and technical strategy for high-throughput DNA sequencing platforms Lead end-to-end design, modeling, and optimization of illumination, imaging, and detection paths Perform optical design, ray tracing, tolerance analysis, and stray-light analysis in Zemax OpticStudio Build, align, test, and characterize optical prototypes and subsystems on the bench Define specs for custom optical components, coatings, and sources; own supplier drawings and acceptance criteria Partner with manufacturing contractors to transfer designs from prototype to volume production Lead the optical system through feasibility, design verification, design transfer, and commercial launch Collaborate with mechanical, electrical, software, and assay teams for full instrument integration What You Bring M.S. or Ph.D. in Optical Engineering, Optical Sciences, Physics, Electrical Engineering, or related field 10+ years of optical engineering/system design experience with multiple products commercialized Expert-level Zemax OpticStudio (sequential and non-sequential modeling, optimization, tolerancing) Hands-on bench experience with optical alignment, testing, and characterization Experience working with CRO/CDMOs and contract manufacturers on make-vs-buy and design transfer Deep knowledge of aberrations, diffraction, radiometry, polarization, and detector/sensor selection Preferred: experience with ultra-high-sensitivity detection (fluorescence, single-molecule, low-light imaging) and life science/genomics/diagnostics instruments Compensation & Benefits $175,000–$210,000/year (DOE) Medical, dental, vision; company-paid life insurance; 401(k); generous PTO

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.

Principal Supplier Quality Engineer | Fremont, CA (Onsite 3x/week with up to 50% travel to South Bay) We're looking for a Principal Supplier Quality Engineer to build our supplier quality management program from the ground up. This is a brand-new role — you'll be the dedicated supplier quality authority, owning the full lifecycle of supplier qualification, auditing, monitoring, and performance management for a fast-growing medical device company. You'll wear multiple hats, partner cross-functionally, and have real influence in shaping how we manage suppliers as we scale. What You'll Do Design, implement, and continuously improve our Supplier Quality Management Program — supplier qualification, controls, auditing, monitoring, and risk management Lead qualification and oversight of contract manufacturers, sterilization providers, and critical suppliers Plan, conduct, and report on supplier audits and assessments Own SCAR management from initiation through effectiveness verification Investigate supplier quality issues, drive root cause analysis and corrective action Build and maintain supplier scorecards, risk profiles, and performance metrics Partner cross-functionally with Engineering, Operations, Manufacturing, Supply Chain, and Regulatory Affairs Support FDA inspections, notified body audits, and customer audits Apply risk-based decision-making per ISO 14971 What You Bring 8-10+ years of Quality Assurance / Supplier Quality experience in the medical device industry Strong working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971 Proven experience qualifying, auditing, and managing suppliers, including SCAR management Background in medical robotics, orthopedic implants, capital equipment, or electromechanical devices strongly preferred but not required Experience building a supplier quality program from scratch a big plus ASQ CQE, CSQP, CQA, or ISO 13485 Lead Auditor certification preferred Comfortable with up to 50% travel to our primary supplier located in South Bay Logistics Onsite 3 days/week when not traveling to South Bay Supplier Full medical, dental, and vision; KPI-based bonus; stock options Please note: this role is not eligible for visa sponsorship, including TN visas

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.

Product Manager – Ophthalmology Role Overview Our client is seeking a commercially driven Product Manager – Ophthalmology to lead UK brand strategy and portfolio growth. The role combines brand ownership, commercial execution, stakeholder engagement, and cross-functional leadership to improve business performance and patient impact. Key Responsibilities Own and execute the UK brand strategy in line with regional priorities. Drive product performance through KPI monitoring, insights, and growth opportunities. Develop compliant promotional campaigns and omnichannel initiatives to maximise engagement. Partner with commercial, medical, market access, regulatory, and field teams to deliver local plans. Build relationships with external experts, healthcare professionals, and professional associations. Adapt regional campaigns and support congresses, advisory boards, education, and promotional meetings. Qualifications and Experience Degree in life sciences, marketing, business administration, or related discipline; advanced degree advantageous. Proven pharmaceutical product management, brand management, or commercial marketing experience. Strong ophthalmology experience required; dry eye, ocular surface disease, or related expertise preferred. Track record of driving product growth in a competitive pharmaceutical environment. Experience in international or matrix organisations, with strong UK healthcare and ophthalmology market knowledge. Experience partnering with field teams and supporting commercial excellence. Key Competencies Results-focused, commercially astute, and committed to KPI delivery. Entrepreneurial, accountable, and comfortable in a global corporate environment. Adaptable and collaborative, with the ability to create urgency when needed. Strategic thinker with strong communication skills and a bias for action.

Position Overview Lead Quality Operations and the Quality Management System (QMS) for a San Diego manufacturing site, ensuring compliance with regulatory, customer, and business requirements. This role provides strategic and operational leadership across Quality Assurance and Quality Control, drives continuous improvement and risk management, and partners closely with site leadership to strengthen product quality, operational performance, and customer satisfaction. Reports to the Quality Director and works cross-functionally with Operations, Production, Engineering, Customer Service, and Sales. Responsibilities 🔹 Own the QMS and Quality Operations, ensuring compliance with regulatory, customer, and business requirements 🔹 Provide leadership, coaching, talent development, and performance management for QA/QC teams 🔹 Develop and maintain quality systems, procedures, controls, and metrics to ensure consistent product and process quality 🔹 Establish quality objectives and KPIs aligned with business goals 🔹 Lead quality risk management across products, processes, suppliers, and quality systems throughout the product lifecycle 🔹 Ensure effective management of CAPA, nonconformances, deviations, complaints, adverse events, and change controls 🔹 Lead Management Reviews and report quality performance, compliance, risks, and improvement initiatives to executive leadership 🔹 Direct internal, supplier, customer, certification, and regulatory audit programs, ensuring timely closure of findings 🔹 Ensure audit readiness and lead Quality representation during inspections 🔹 Establish and maintain a supplier quality management program, including qualification, monitoring, audits, and performance reviews 🔹 Promote a prevention-based quality culture through training, risk management, and continuous improvement initiatives Requirements ✅ Bachelor's degree in Engineering, Manufacturing, Quality, or a related field ✅ 5–7 years of experience in Engineering and/or Quality, preferably in medical device ✅ 3+ years in a supervisory or management role ✅ Experience with quality risk management principles in a regulated manufacturing environment ✅ Expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes ✅ Track record leading teams and driving continuous improvement in quality, compliance, and business performance ✅ Proficient in MS 365 applications ✅ Experience with ERP/MRP systems, electronic QMS (eQMS), and data analytics/reporting tools ✅ Comfortable working in both office and manufacturing environments, including occasional lifting up to 25 lbs

Own the technical launch of a brand-new medical device production line, from first specs through full qualification and ramp-up. This is a hands-on, high-visibility role for someone who wants to be the go-to technical owner for a line — not just a contributor to one. Responsibilities: 🔹 Line specs, layout, capacity, cycle time, and staffing to meet business needs 🔹 Production builds — component availability, design configurations, special builds 🔹 Key production metrics: yield, scrap, throughput, cycle time, OEE, uptime, process capability 🔹 Design transfer from R&D into operations — bridging development through qualification and launch 🔹 Equipment procurement, installation, commissioning, and ramp-up 🔹 PFMEAs, control plans, process risk assessments, and validation protocols (IQ/OQ/PQ) 🔹 Continuous improvement, capacity expansion, and cost-reduction initiatives Required Experience: ✅ Bachelor's in Mechanical, Manufacturing, Biomedical, Industrial, or Electrical Engineering ✅ 5+ years in manufacturing or process engineering ✅ Direct experience standing up and managing a new production line for a medical device — not just operating an already-mature line ✅Strong grasp of line design efficiency and line balancing (identifying bottleneck/slowest equipment, determining trade-offs on equipment speed) ✅ Hands-on with equipment specification, installation, commissioning, and process validation ✅ Strong grasp of DOE, SPC, process capability, and root-cause analysis ✅ Comfortable owning cross-functional communication across Manufacturing, Quality, R&D, Ops, and Supply Chain ✅ Medical device or other regulated manufacturing background ✅ ISO 13485, process validation, and manufacturing risk management knowledge ✅ Experience with automated assembly, dispensing, bonding, inspection, packaging, or test equipment ✅ Lean/Six Sigma, OEE, PFMEA, and control plan experience 📍 On-site in Irvine, CA — regular cleanroom work, with frequent commute to San Diego for business meetings

Marketing Manager Pharma (m/f/d) About the role Our client is a specialist pharmaceutical company operating across Europe, focused on hospital-based therapies. Your role You will lead brand and marketing activities across European markets, working with Sales, Medical Affairs and external partners to deliver compliant campaigns that strengthen brand presence and support growth. Your tasks and responsibilities Plan and execute marketing activities across the product portfolio. Develop digital content, campaign materials and website updates. Support Sales with effective marketing tools and materials. Coordinate congresses, multichannel activities, budgets and timelines. Your profile Degree in Marketing, Business Administration, Life Sciences or a related field. Two to three years’ experience in pharmaceutical or healthcare marketing. Experience with digital content, prescription products or regulated environments. Strong communication, organisation and stakeholder-management skills. Excellent English; German is highly desirable. What we offer High ownership and scope to shape marketing activity. Small, experienced and collaborative team. Flexible working, partial remote work and additional benefits.

Senior Android Software Engineer — San Diego (On-site, Medical Device) A growing medical device company is looking for a Senior Android Engineer to join a small, tight-knit mobile team building software that's an integral part of a connected medical device ecosystem. This is a high-impact role at the intersection of mobile software, connected hardware, and patient care. What makes this role different: 🔹 100% native Android development in Kotlin — no cross-platform frameworks 🔹 You'll own complex features end-to-end — design through implementation, verification, release, and post-market support 🔹 Work directly with embedded, cloud, systems, cybersecurity, and regulatory teams 🔹 BLE and connected-hardware experience is a big plus 🔹 Open to Sr. SWE or Technical Lead level, depending on background — room to grow into a leadership track What they're looking for: ✅ 7+ years professional software development, strong Android focus ✅ Advanced Kotlin, Jetpack Compose, Coroutines/Flow, modern Android architecture ✅ Experience building apps that run reliably in the background — handling connectivity drops, OS restrictions, device restarts ✅ A genuine Android enthusiast — someone who's plugged into the platform and excited by new OS releases ✅ You've personally shipped an app to the Play Store ✅ Medical device, digital health, or other highly regulated industry background (DoD, etc. also considered) ✅ Strong ownership mentality — you build it right the first time Details: 📍 San Diego, CA — on-site, hybrid Tues–Thurs in office 💰 Competitive base + RSUs + bonus 🚫 No visa sponsorship available

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

🚀 We're Hiring: Director of Medical Operations — San Francisco An innovative consumer health technology company is looking for a Director of Medical Operations to lead manufacturing operations and design verification/validation for their medical products division — working closely with R&D, Clinical, QA/RA, and the executive team. What you'll own: 🔹 Manufacturing controls and process implementation specific to medical-grade products — while maintaining operational velocity 🔹 Global (OUS) manufacturing oversight — hands-on partnership with international manufacturing partners across varying quality maturity levels 🔹 Design verification and validation testing efforts, in close collaboration with R&D and QA/RA 🔹 Risk management documentation guidance across cross-functional engineering teams 🔹 Bridging QA/RA and Engineering to accelerate medical product upgrades from the consumer platform What you bring: ✅ 8+ years in operations or manufacturing for medical devices, ideally with a background spanning both medical-grade and consumer product environments ✅ Track record supporting successful FDA clearances (510(k), De Novo) ✅ Experience managing and initiating global manufacturing initiatives (Asia, Mexico, etc.) — comfortable being hands-on when something breaks and needs a boots-on-the-ground fix ✅ Strong cross-functional program management across Engineering, QA/RA, and Manufacturing ✅ Bachelor's degree or equivalent experience

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.

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 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).

No C2C or Visa Sponsorship Available Staff Quality Engineer 📍 San Diego, CA — Onsite BioTalent is hiring a Staff Quality Engineer for a medical device company in San Diego to own and continuously improve their Quality Management System across the full product lifecycle. This is a hands-on, high-ownership role reporting directly to the VP. Responsibilities: Coordinate and maintain QMS processes and documentation across the organization Lead the design control program in partnership with R&D, clinical, and operations Represent Quality within the change control system — reviewing and approving changes Lead CAPA activities including root cause analysis, problem definition, and effectiveness checks Support NMR and complaint handling, supplier qualification, and incoming inspection Lead the internal audit program and support external audit and inspection readiness Requirements: B.S. in a technical discipline 8-10+ years in a quality role within a medical device manufacturing environment 3+ years of quality system auditing experience Strong command of ISO quality systems and harmonized standards for medical devices Hands-on execution experience Nice to have: Software-enabled/connected device experience, FDA inspection support, MDR/CE marking, diabetes clinical space background

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

Job Title: Senior Biomedical Engineer Works closely with and have impact on: Global Quality, Global Regulatory, Operations Reports to: Director of Biomedical Research Function: Research & Development Work Location/Site: Irvine, CA Role Overview The Senior Biomedical Engineer is a subject matter expert for biocompatibility of ophthalmic medical devices, with a primary focus on intraocular lenses (IOLs). This role requires in-depth expertise in ISO 11979-5 and the ISO 10993 series, combined with a strong background in materials science, analytical chemistry, and chemistry-based testing. The individual will function as a contributor, providing scientific leadership to support product development, regulatory compliance, and biocompatibility related activities. Duties and Responsibilities Serve as the biocompatibility subject matter expert for intraocular lenses (IOLs) and associated delivery systems. Develop and execute biological evaluation strategies in accordance with ISO 10993-1, ISO 11979-5, and related standards. Design, review, and interpret analytical and chemistry-based testing data (e.g., GC-MS, HPLC, LC-UV) and translate results into regulatory-relevant conclusions. Manage and technically oversee external CROs, including protocol review, study oversight, and report review. Perform biological evaluations, risk assessments, safety risk impact assessments (SRIAs), and gap assessments to identify testing needs, scientific rationales, and risk mitigations. Collaborate cross-functionally with R&D, Regulatory Affairs, Quality, Manufacturing, and Supplier Quality teams. Write and review detailed technical reports to support global biocompatibility related matters ensuring scientific rigor, clarity, and compliance with regulatory standards and internal quality systems. Requirements Experience Minimum of 5–7 years of experience in biomedical research, medical device biocompatibility, or related fields. Direct experience supporting biocompatibility assessments for implantable medical devices, preferably ophthalmic devices. Hands-on experience with analytical and chemistry-based testing in support of biocompatibility (e.g., E&L, material characterization). Experience authoring protocols, technical reports, and regulatory-facing documentation. Skills/Accreditations Expert-level proficiency in ISO 11979-5 and ISO 10993 series standards. Strong background in materials science, polymer chemistry, and analytical sciences. Experience with analytical techniques such as GC-MS, HPLC, LC-UV, ICP-MS, etc. Excellent technical writing and report authoring skills. Strong risk assessment, critical thinking, and problem-solving abilities. Excellent communication and cross-functional collaboration skills. Academic Qualifications Master's degree or PhD in Materials Science, Biomedical Engineering, Chemistry, Analytical Sciences, or a closely related field. Advanced academic training with a strong emphasis on chemistry and analytical techniques is required. Travel Requirements None

We’re partnering with a high-growth, global life sciences manufacturer at the forefront of bioprocessing and single-use technologies . They’re hiring a Quality Engineer to drive quality performance across complex, GMP manufacturing operations supporting leading biopharma customers. The Role Lead quality investigations (complaints, non-conformances, sterility issues) Own root cause analysis + CAPA delivery Partner cross-functionally across Manufacturing, Engineering, R&D, and Supply Chain Drive continuous improvement (Lean / Six Sigma / SPC) Act as key interface for customer, supplier, and regulatory quality topics Support GMP, cleanroom, and validation-driven manufacturing processes What They Need Experience in biotech / pharma / medtech manufacturing environments Strong grounding in QMS (CAPA, change control, deviations, validation) Exposure to GMP and ISO (9001 / 13485 / FDA) Proven ability to solve complex manufacturing quality issues Comfortable operating in a fast-paced, cross-functional environment Why This Role High-impact role supporting cutting-edge biopharma manufacturing Exposure to complex, high-value products and global customers Opportunity to drive real operational and quality improvements at scale

We’re partnering with a high-growth, global life sciences manufacturer at the forefront of single-use bioprocessing technologies . They’re hiring an NPI Quality Engineer to sit at the intersection of R&D, Manufacturing, and Quality , ensuring new products are designed, validated, and successfully launched into GMP production. The Role Act as Quality lead across New Product Introduction (NPI) programmes Drive design controls, risk management (DFMEA / PFMEA), and validation activities (IQ/OQ/PQ) Ensure manufacturing readiness for product launch (builds, documentation, transfer) Support sterilisation validation (EO, Gamma, E-beam) for single-use products Partner cross-functionally to deliver robust, scalable manufacturing processes Contribute to CAPA, change control, and continuous improvement What They Need Experience in biotech / pharma / medtech manufacturing quality Strong knowledge of ISO 13485 / 9001, GMP, and design controls Hands-on experience with validation, risk management, and product transfer Exposure to cleanroom manufacturing and sterile products Ability to operate across cross-functional product development teams Why This Role Direct impact on bringing new products to market Work at the cutting edge of bioprocessing and single-use technologies Opportunity to influence product quality from design through to scale

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

e’re partnering with a high-growth, global life sciences manufacturer scaling rapidly across complex, regulated supply chains . They’re hiring a Supplier Quality Engineer to own supplier performance, drive compliance, and ensure externally sourced materials meet the highest quality and regulatory standards. The Role Lead supplier qualification, audits, and onboarding Own supplier performance (KPIs, scorecards, continuous improvement) Drive SCARs, root cause analysis, and CAPA effectiveness Support supplier-related validation and change control activities Partner cross-functionally across Supply Chain, Engineering, and Manufacturing Ensure compliance with FDA, ISO 13485, and global regulatory standards What They Need Experience in medical device / biopharma quality environments Strong knowledge of supplier quality, audits, CAPA, and risk management Proven ability to manage supplier performance and drive improvement Confident operating in regulated, multi-site supply chains Ability to lead audits and influence both internal and external stakeholders Why This Role High-impact role across a global supplier network Direct influence on product quality and regulatory compliance Opportunity to shape and elevate supplier quality strategy at scale

We’re partnering with a rapidly scaling, global life sciences manufacturer investing heavily in quality, compliance, and operational excellence . They’re hiring a Director, Quality Operations to lead and evolve site-wide quality systems, drive performance, and build a best-in-class quality function. The Role Own and optimise the site Quality Management System (ISO 9001 / 13485 / cGMP) Lead CAPA, non-conformance, audit, and inspection frameworks Oversee high-risk investigations and product quality decisions Drive continuous improvement across quality operations Lead, mentor, and scale a high-performing quality team Partner cross-functionally to ensure quality at scale across products and regions What They Need Proven leadership in pharma, biotech, or medical device manufacturing Deep expertise in QMS, audits, CAPA, and regulatory compliance Strong track record of driving quality transformation in scaling environments Ability to influence at senior level and operate cross-functionally Why This Role Senior leadership role with direct impact on global quality performance Opportunity to shape and scale quality systems in a high-growth environment Visibility with executive leadership and influence over strategic direction

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.

Director of Alliance Management Location: Remote (Europe) Drive Impact. Own Outcomes. Shape Global Partnerships. An ambitious, fast-growing global life sciences company is looking for a high-impact Director to take full ownership of some its most critical partnerships. This is not a traditional relationship role—this is a commercial position with P&L accountability and the opportunity to directly influence growth, profitability, and long-term success. If you thrive in a results-driven environment, enjoy taking full ownership, and know how to turn partnerships into high-performing commercial assets, this role offers a unique platform to make a measurable impact. What You’ll Do Own the numbers – take full accountability for revenue, costs, and margin across key alliances. Drive performance – lead business planning, forecasting, and delivery of financial targets. Lead from the front – act as the senior commercial owner and trusted partner contact. Make things happen – mobilise cross-functional teams to deliver against milestones and commitments. Solve complex challenges – proactively identify risks, fix underperformance, and protect value. Shape deals – lead contract management, renegotiations, and strategic improvements. Unlock growth – identify new opportunities to expand and optimise partnerships. Influence at the top – present insights and recommendations directly to senior leadership. What You Bring 8+ years’ experience in alliance management, business development, or commercial roles within life sciences. Proven success owning and managing P&L performance in complex partnerships. Strong commercial acumen with experience negotiating and managing high-value contracts. Confidence working across global, matrixed organisations and driving accountability. A track record of delivering results, solving problems, and making tough decisions. Excellent communication skills with the ability to influence senior stakeholders. Degree required; MBA or equivalent is a plus. Why Join? High visibility, high impact role with direct influence on commercial performance Opportunity to own and shape strategic partnerships globally Work in a dynamic, growth-focused environment that values ownership and results Competitive package and strong career progression potential

Senior Manager, Clinical Operations Boston, Massachusetts – Onsite A growing clinical research organization is seeking a Senior Manager, Clinical Operations 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 2+ 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 strongly preferred

Nurse Practitioner or Physician Assistant Boston, Massachusetts | Onsite | Full Time Position Overview A growing clinical research organization is seeking a full-time, onsite Psychiatric Nurse Practitioner or Physician Assistant in Boston. 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.

VP of Marketing Location: Zurich area (hybrid) · also open to Berlin or London Contract: Permanent, full-time Reporting to: Chief Growth Officer We are hiring a Head of Brand / Growth to build and scale an acquisition engine from the ground up. This is a 0→1 role —-ideal for someone who enjoys solving complex growth challenges rather than optimising existing playbooks. Key Responsibilities Lead paid acquisition across key digital channels (e.g. display and search), managing substantial annual budgets Build and scale growth loops and campaigns across multiple international markets Improve attribution, tracking, and reporting across the full customer journey Develop and optimise lifecycle marketing strategies across relevant channels Translate customer insights into effective messaging, landing pages, and creative in collaboration with cross-functional teams Skills & Experience Required Proven experience scaling paid acquisition on platforms such as Meta, Google, or similar within a startup environment (not agency-side) Track record of managing significant performance marketing budgets with full ownership of reporting Strong familiarity with analytics and marketing tools, including GA4, GTM, and CRM platforms (e.g. HubSpot, Salesforce, Pipedrive) Understanding of multi-touch attribution tools (e.g. Dreamdata, HockeyStack or similar) is advantageous Experience working on B2C / DTC products with high average order values (4-figure range) , or comparable B2B SMB offerings About You Analytical and data-driven, with a strong product-oriented mindset Comfortable making decisions with incomplete or ambiguous data Focused on customer understanding rather than relying on channel tactics alone Able to think from first principles and build scalable growth systems Highly self-sufficient, with the ability to identify and solve problems independently Adaptable, with experience across different companies, products, or growth stages Brings 0→1 experience , having built or significantly shaped a growth function from scratch

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.