Director, Epidemiology & Evidence Strategy

Overview

In this Director role, you will shape the epidemiology and evidence strategy for a confidential multi-indication portfolio. You will lead epidemiology across regulatory, clinical, and commercial objectives, and serve as the senior scientific authority on disease burden and natural history. You will guide observational studies and methodological rigor, and partner with cross-functional teams to integrate epidemiology into submissions and lifecycle planning. This position offers high-impact regulatory collaboration and an opportunity to build internal epidemiology capabilities and governance. You will drive credible, data-rich evidence that supports risk management and decision-making at the-?

Responsibilities

• Set the overarching epidemiology strategy for the portfolio aligned with regulatory, clinical, and commercial goals
• Act as the senior scientific authority on disease burden, natural history, and background incidence for priority indications
• Represent epidemiology at governance forums and advise on risks and evidence gaps
• Build and lead a team of epidemiologists with mentorship and scientific standards
• Design and oversee observational studies including natural history studies, registries, and post-authorization studies
• Provide methodological oversight on bias, confounding, and causal inference methods
• Lead development of study protocols, SAPs, and regulatory submission sections
• Ensure epidemiological rigor from concept to publication
• Author/review epidemiological content for regulatory submissions and health authority responses
• Collaborate with Biostatistics, Pharmacovigilance, Medical Affairs, and Health Economics to integrate epidemiology into broader evidence packages
• Provide epidemiological input into signal detection and benefit-risk assessment

Key requirements

• PhD in Epidemiology (or closely related discipline)
• 12+ years of epidemiology experience in pharma/biotech/public health with leadership experience
• Deep expertise in observational study design, causal inference, and pharmacoepidemiology methods
• Experience authoring epidemiological content for regulatory submissions and regulatory interactions
• Track record of leading and developing epidemiology teams
• Strong scientific writing and publication record
• Excellent stakeholder management with experience presenting to senior governance and regulatory bodies

• leadership
• stakeholder management
• scientific writing
• observational study design
• causal inference
• pharmacoepidemiology methods

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