Director, Epidemiology & Evidence Strategy

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