Senior Director of Epidemiology

About the role

Beeline Medicines seeks a senior leader to provide scientific and strategic epidemiology expertise across its development portfolio. The role focuses on generating fit‑for‑purpose evidence that informs medical affairs, clinical development, safety, regulatory and commercial decisions.

Key responsibilities

• Design and oversee observational studies, disease registries, natural history studies and systematic literature reviews.
• Provide epidemiologic input to clinical development plans, study protocols, endpoint strategy and safety assessments.
• Partner with cross‑functional teams (Clinical Development, Drug Safety, Regulatory, HEOR, Commercial) to conduct evidence gap analyses and develop integrated evidence generation plans.
• Lead cross‑functional program teams as the epidemiology expert, advising on disease burden, comparator data and regulatory/HTA evidence requirements.
• Author and review epidemiology sections of regulatory submissions, risk management plans and scientific publications.
• Evaluate and integrate real‑world data sources such as claims databases, EHRs and registries to support safety and effectiveness assessments.

Required profile

• PhD, ScD or equivalent doctoral degree in Epidemiology, Public Health or a related field.
• At least 8 years of epidemiology experience in pharma, biotech, academia or public health, with a proven record of leading observational research.
• Demonstrated ability to design, execute and interpret real‑world evidence studies that inform regulatory, development or commercial decisions.
• Strong understanding of pharmacoepidemiology methods, bias control and regulatory frameworks for RWE.
• Excellent scientific writing and presentation skills for regulatory, publication and executive audiences.

Required skills

• Proficiency with statistical software such as SAS or R for epidemiologic analysis.
• Experience analyzing real‑world data sources (claims, electronic health records, registries).
• Expertise in epidemiologic study designs (cohort, case‑control, registry‑based).
• Knowledge of FDA RWE guidance and payer/HTA evidence expectations.

What we offer

• Competitive health and wellness coverage.
• Paid time off and public holidays in accordance with local regulations.
• Hybrid work schedule with flexibility.
• Discretionary annual bonus and long‑term equity incentives.