About the role
- london, United Kingdom
- Contract
Director, Epidemiology & Evidence Strategy
- Europe, United States
- Permanent
Permanent | Global Pharmaceutical Company
Overview
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
1. 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
2. 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
3. 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
52731 | Posted: 11/08/2026
- Europe, United States
- Permanent
Permanent | Global Pharmaceutical Company
Overview
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
1. 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
2. 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
3. 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
About this listing
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