At a Glance
- Tasks: Lead epidemiological strategy and oversee evidence generation for late-stage pharmaceutical assets.
- Company: Join a global pharmaceutical company making a real impact in healthcare.
- Benefits: Competitive salary, career development, and the chance to shape public health strategies.
- Other info: Opportunity to build and mentor a team in a dynamic, impactful environment.
- Why this job: Be at the forefront of epidemiology, influencing regulatory submissions and risk management.
- Qualifications: PhD in Epidemiology and 12+ years of relevant experience required.
The predicted salary is between 63000 - 77000 Β£ per year.
We are partnering with a large, global pharmaceutical organisation to appoint a Director, Epidemiology & Evidence Strategy to lead epidemiological input across a confidential portfolio of late-stage assets. This is a senior scientific leadership role, responsible for shaping the epidemiological evidence strategy that underpins regulatory submissions, risk management, and lifecycle planning across multiple indications.
Key Responsibilities
- Epidemiological Strategy & Leadership
- Set the overarching epidemiology strategy across the portfolio, aligning with regulatory, clinical, and commercial objectives.
- Serve as the senior scientific authority on disease burden, natural history, and background incidence/prevalence for priority indications.
- Represent epidemiology at senior governance forums, advising on programme-level risk and evidence gaps.
- Build and lead a team of epidemiologists, mentoring junior staff and setting scientific standards across studies.
- Study Design & Evidence Generation
- Design and oversee observational studies, including natural history studies, disease registries, and post-authorisation safety/efficacy studies.
- Provide expert methodological oversight on epidemiological approaches, including bias mitigation, confounding control, and causal inference frameworks.
- Lead development of study protocols, statistical analysis plans, and epidemiological sections of regulatory submissions.
- Ensure epidemiological rigor across all evidence-generation activities, from concept through to publication.
- Regulatory & Cross-Functional Engagement
- Author and review epidemiological content for regulatory submissions, risk management plans, and health authority responses.
- Act as the epidemiology lead in interactions with regulatory agencies, responding to scientific queries.
- Partner closely with Biostatistics, Pharmacovigilance, Medical Affairs, and Health Economics to ensure epidemiological evidence is integrated into broader evidence packages.
- Provide epidemiological input into signal detection and benefit-risk assessment activities.
Impact of the Role
- Shape the epidemiological evidence foundation for a confidential multi-indication portfolio.
- Strengthen the organisation's scientific credibility with regulators through rigorous epidemiological input.
- Build internal epidemiology capability and governance standards.
- Influence long-term lifecycle and risk management strategy across therapeutic areas.
Your Profile
- PhD in Epidemiology (or closely related discipline) required.
- Extensive experience (12+ years) in epidemiology within pharmaceutical, biotech, or public health settings, including senior/leadership experience.
- Deep expertise in observational study design, causal inference, and pharmacoepidemiological methods.
- Demonstrated experience authoring epidemiological content for regulatory submissions and interacting with health authorities.
- Track record of leading and developing epidemiology teams.
- Strong scientific writing and publication record.
- Excellent stakeholder management skills, with experience presenting to senior governance and regulatory bodies.
Director, Epidemiology & Evidence Strategy employer: Barrington James Limited
Join a well-established organisation that values its employees and fosters a supportive work culture. As an HR Associate, you will have the opportunity to be a trusted point of contact, ensuring compliance with employment legislation while contributing to the development of robust people processes. With a focus on employee growth and continuous improvement, this role offers a meaningful career path in a dynamic environment.