Barrington James
Director, Epidemiology & Evidence Strategy
London
Posted 1 day ago
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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
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
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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
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
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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
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Skills
Epidemiological Strategy
Observational Study Design
Causal Inference
Pharmacoepidemiology
Regulatory Submissions
Risk Management Planning
Stakeholder Management
Scientific Writing
Team Leadership
Disease Burden Analysis
Natural History Studies
Disease Registries
Bias Mitigation
Confounding Control
Benefit-Risk Assessment
Clinical Evidence Generation
Location