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About the Role

Regeneron is seeking a Senior Director, Benefit/Risk Medical Adviser EU/UK to provide authoritative medical, safety and benefit-risk advice supporting oversight of authorised products throughout their lifecycle. You will combine clinical judgement with qualitative and quantitative approaches, including patient preferences, real-world data and epidemiological evidence, while partnering with colleagues across Global Patient Safety, Regulatory Affairs, Clinical Development and other functions.

Responsibilities

Advise the QPPV on signal validation, evaluation and prioritisation, benefit-risk assessments, Risk Management Plans and health hazard assessments.
Shape medical and safety strategy across clinical development and the post-authorisation lifecycle, including emerging clinical trial data and evolving safety evidence.
Provide expert input to regulatory submissions, aggregate safety reports, safety communications and responses to health authority questions, requests and referrals.
Apply qualitative and quantitative benefit-risk approaches using clinical, epidemiological, real-world and patient-preference evidence, where appropriate.
Advise on PASS protocols and the appropriate use and interpretation of epidemiology, pharmacoepidemiology and real-world data.
Develop and optimise CCSI, RMP, aggregate reporting and pharmacovigilance processes, identifying gaps and strengthening QPPV oversight.
Partner across safety, regulatory, clinical, quality, legal, commercial, local pharmacovigilance and product supply functions while contributing to governance and inspection readiness.
Provide credible medical challenge, translate complex safety science into clear advice and influence senior stakeholders without direct authority.

Requirements

A medical qualification, such as MBChB, MBBS or MD, with a current or historic medical licence.
Extensive post-qualification experience in drug safety or pharmacovigilance within the pharmaceutical or biotechnology industry, or a health authority.
Deep knowledge of EU GVP and the EU/UK pharmacovigilance legislative framework, with working knowledge of US FDA safety reporting requirements.
Proven expertise in signal evaluation, qualitative and quantitative benefit-risk assessment, risk management planning and the safety aspects of regulatory submissions.
Strong knowledge of relevant ICH guidelines and the application of real-world, epidemiological and pharmacoepidemiological evidence.
Authoritative medical judgement, clear scientific communication and the ability to operate credibly with senior and cross-functional stakeholders.
Experience supporting or deputising for a QPPV, working within a QPPV Office, or supporting inspections and audits is preferred.
A Pharmaceutical Medicine qualification, specialist registration or experience across additional regulatory jurisdictions is preferred.
Experience applying patient-preference evidence or quantitative benefit-risk methods, or an additional EU language relevant to the location, is preferred.

Skills

Signal validation
Signal evaluation
Signal prioritisation
Benefit-risk assessments
Risk Management Plans
Health hazard assessments
Medical strategy
Safety strategy
Clinical development
Post-authorisation lifecycle
Regulatory submissions
Aggregate safety reports
Safety communications
Health authority questions
Qualitative benefit-risk approaches
Quantitative benefit-risk approaches
Clinical evidence
Epidemiological evidence
Real-world data
Patient-preference evidence
PASS protocols
Epidemiology
Pharmacoepidemiology
CCSI development
RMP development
Aggregate reporting
Pharmacovigilance processes
Cross-functional collaboration
Scientific communication
Stakeholder influence

Location

Uxbridge (Hybrid)

Work Type

Hybrid

Experience Level

Senior Director
Extensive post-qualification experience

Education Level

Medical qualification (MBChB, MBBS or MD)
Current or historic medical licence
Pharmaceutical Medicine qualification (preferred)

Benefits

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Insurance benefits (medical, dental, vision, life and disability)
Paid time off
Family support benefits

About the Company

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

Equal Opportunity

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.