Senior Director, Medical Affairs - Medical Excellence

Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis.

The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments.

With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.

We are looking for an experienced, strategic and highly collaborative Senior Director, Medical Affairs – Medical Excellence to establish and lead the capabilities required for Medical Affairs as Oxford Nanopore expands the clinical application of its technology and its regulated IVD portfolio.

The Details…

The Senior Director Medical Affairs will establish the foundations of a scalable and high-performing Medical Affairs capability, defining how Medical Affairs operates and how medical and scientific insight contributes to Oxford Nanopore's clinical and product strategy.

The job will entail developing medical strategies aligned with priority clinical applications and products, identifying unmet medical needs, evidence gaps, key external stakeholders and the scientific activities required to support responsible clinical adoption of Oxford Nanopore technology.

Responsibilities will include….

Medical Strategy and Insights:

• Develop Medical Affairs strategies for priority products, disease areas and clinical applications, aligned with Oxford Nanopore's broader clinical and business strategy.
• Identify clinical unmet needs, evidence gaps and barriers to clinical adoption and translate these into clear Medical Affairs priorities and evidence-generation plans.
• Establish mechanisms to systematically capture medical and scientific insights from healthcare professionals, laboratory professionals, investigators, KOLs, customers and other external stakeholders.
• Ensure relevant medical insights are synthesised and communicated to R&D, Product, Clinical, Regulatory and Commercial teams to inform product and evidence strategy.
• Act as a senior medical and scientific partner in the assessment of emerging clinical opportunities for Oxford Nanopore technology.

Medical Affairs Excellence and Governance

• Establish and continuously develop the Medical Affairs operating model, including governance, processes, procedures, roles and responsibilities, documentation standards, systems, metrics and interfaces with other functions.
• Develop appropriate standards and processes for Medical Affairs activities to ensure scientific quality, consistency, transparency and compliance across markets.
• Establish Medical Affairs KPIs and effectiveness measures to assess the impact of evidence generation, scientific engagement, medical education and other Medical Affairs activities.
• Build scalable Medical Affairs capabilities capable of supporting Oxford Nanopore's continued expansion across geographies, clinical applications and regulated products.

Evidence Generation and Investigator-Initiated Studies

• Develop an integrated medical evidence-generation pipeline, working across functions to identify, prioritise and address evidence gaps relevant to clinical adoption, product strategy and lifecycle management.
• Establish and govern a global Investigator-Initiated Studies programme, including transparent processes for submission, scientific and medical review, prioritisation, approval, contracting, funding, oversight and dissemination.
• Partner with Clinical Affairs and other evidence-generation functions to ensure alignment between company-sponsored clinical studies, investigator-led research, real-world evidence and broader Medical Affairs evidence priorities.
• Support appropriate publication and scientific dissemination strategies to ensure clinically relevant evidence is communicated effectively to the medical and scientific community.

KOL and External Scientific Engagement

• Establish a structured KOL and external expert management framework, including identification, segmentation, engagement planning, documentation and measurement of scientific engagement.
• Develop standards and governance for scientific advisory boards, ensuring clear scientific objectives, appropriate expert selection, compliant contracting and remuneration, high-quality scientific discussion and systematic capture of actionable insights.
• Establish appropriate Medical Affairs capabilities for scientific exchange, enabling evidence-based, balanced and non-promotional engagement with healthcare professionals, laboratory professionals, researchers and other scientific stakeholders.
• Develop strong relationships with relevant clinical and scientific communities and ensure external perspectives inform Oxford Nanopore's medical and clinical strategy.

Medical Safety and Product Risk

• Establish a medical safety and medical review capability for regulated IVD products, providing medical expertise to complaint escalation, potential safety signals, assessment of clinical harm and health hazards, vigilance activities and other medically significant post-market issues.
• Partner closely with Quality, Regulatory Affairs and Post-Market Surveillance teams to ensure medical assessments appropriately inform risk management and product safety activities.
• Provide medical expertise into ISO 14971 risk management activities, including assessment of clinical severity, foreseeable harms, benefit-risk considerations and medical interpretation of emerging safety information.
• Support Health Hazard Assessments and other medically driven safety assessments where medical judgement is required.
• Ensure an effective connection between medical safety information, post-market experience, evidence generation and Medical Affairs strategy.

LDT and In-House Testing

• Establish a Medical Affairs framework for compliant scientific support of Laboratory Developed Tests in the United States and in-house devices/tests under the EU IVDR.
• Work closely with Regulatory Affairs, Quality and Legal/Compliance to establish clear principles and operating boundaries for Medical Affairs interactions with laboratories developing or operating such tests.
• Enable appropriate scientific exchange and evidence generation while ensuring activities remain consistent with product regulatory status, intended use and applicable requirements.
• Develop appropriate Medical Affairs guidance and training for customer-facing teams interacting with laboratories operating in these environments.

New Product Development and Lifecycle Management

• Act as a senior Medical Affairs partner to R&D, Product, Clinical and Regulatory Affairs throughout new product development.
• Ensure that clinical unmet need, intended use, target populations, clinical workflows, medical risks and evidence requirements are appropriately considered in product strategy and development.
• Contribute medical expertise to relevant design control and risk management activities, while maintaining clear functional accountability between Medical Affairs, Clinical, Regulatory Affairs, Quality and R&D.
• Provide medical input into product claims and evidence requirements and support alignment between intended use, clinical evidence, scientific communication and lifecycle strategy.
• Bring external medical and scientific insight into development programmes to ensure that products and evidence strategies address clinically meaningful needs.

Medical Education and Commercial Partnership

• Establish processes for translating emerging clinical and scientific evidence into appropriate medical strategy, scientific communication and education.
• Develop and deliver high-quality medical and scientific training for Commercial and other customer-facing teams, including disease and clinical pathway education, evidence interpretation, appropriate scientific claims and the boundaries of compliant communication.
• Support the development and medical review of scientific and educational materials to ensure scientific accuracy, balance and consistency with the available evidence and regulatory status of Oxford Nanopore products.
• Partner with Commercial teams while maintaining the appropriate independence and scientific integrity of Medical Affairs.

What We’re Looking For…

The successful candidate will be an experienced Medical Affairs leader who combines strong scientific and clinical judgement with the ability to build capabilities, establish governance and translate medical strategy into execution.

• An advanced degree in medicine, life sciences or a related discipline, or equivalent experience.
• Significant Medical Affairs experience within the diagnostics, medical device, life sciences or pharmaceutical industry, with demonstrated experience establishing or leading Medical Affairs programmes and working cross-functionally in regulated environments.
• Demonstrated experience developing medical strategies and translating clinical and scientific needs into executable Medical Affairs plans.
• Experience across several of the following areas: evidence generation, investigator-initiated studies, KOL engagement, advisory boards, scientific exchange, medical education, medical governance, medical safety and product lifecycle support.
• Experience within molecular diagnostics, genomics, sequencing, precision medicine or other complex diagnostic technologies is highly desirable.
• A strong working knowledge of regulated product development and lifecycle requirements relevant to diagnostics, including ISO 13485, ISO 14971, FDA IVD requirements, applicable 21 CFR requirements and EU IVDR, together with an understanding of clinical/performance evidence, post-market surveillance and vigilance requirements.
• Excellent scientific communication and writing kills.
• Pragmatic problem solver, and an effective senior cross-functional leader.

• Ability to prioritise competing requirements, influence without direct authority and make sound decisions in situations where information may be incomplete.

If you are looking to utilise your skills to really make a difference to humankind, then consider joining our team and apply today!

Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.