Senior Director, Epidemiology

About the role

The Senior Director of Epidemiology will provide scientific and strategic epidemiology leadership across Beeline Medicines’ development portfolio, with particular emphasis on generating fit-for-purpose evidence that informs medical affairs, clinical development, safety, regulatory, and commercial decision-making. They will lead the design and execution of natural history studies, registries and real-world evidence data generation. The Senior Director will serve as a subject-matter expert on epidemiologic methods and their application across the product lifecycle, contributing to cross-functional program teams through evaluating disease burden, comparator data, and performing systematic literature reviews. By partnering with cross-functional colleagues and external experts, the Senior Director of epidemiology will ensure scientific and operational quality, and help strengthen Beeline’s epidemiology and real-world evidence capabilities, standards and external scientific presence.

Responsibilities

• Design, oversee and interpret observational studies, disease registries, natural history studies, systematic literature reviews and analyses of real-world data
• Provide epidemiologic input to clinical development plans, study protocols, endpoint strategy, disease characterization, patient population definition, safety signal detection and benefit-risk assessments
• Partner with Clinical Development, Drug Safety, Regulatory Affairs, Biostatistics, Medical Affairs, HEOR/Market Access and Commercial colleagues to conduct evidence gap analyses and translate into prioritized, integrated evidence generation plans spanning pre-approval through post-launch
• Serve as epidemiology lead on cross-functional program teams, advising on disease burden, incidence/prevalence, unmet need, standard-of-care and comparator data, and the evidence requirements of regulators, payers and HTA bodies.
• Author and review epidemiology sections of regulatory submissions, risk management plans, and scientific publications, and contribute to publication and scientific communication planning consistent with GPP and ICMJE standards.
• Present epidemiological findings to internal leadership, external advisory boards, and regulatory agencies as needed.
• Evaluate and integrate real-world data sources (such as claims database, EHR, trial registries) to support safety and effectiveness assessments
• Contribute to business development/due diligence assessments involving epidemiological data.
• Provide epidemiologic and real-world evidence content to Medical Affairs activities; field medical scientific training, advisory board and congress materials, medical information responses, and scientific review of investigator-sponsored research proposals.
• Contribute to departmental strategy, annual planning, resource forecasting and evaluation of external data sources and research capabilities
• Develop, maintain and