Senior Director, Epidemiology

Job Summary:

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.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and 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 improve epidemiology standards, process guides, templates and quality practices consistent with applicable regulations and company procedures, including secondary-data governance (data use agreements, HIPAA/GDPR and other privacy requirements, IRB/ethics review) and observational study registration and transparency expectations.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: PhD, ScD, or equivalent doctoral degree in Epidemiology, Public Health, or a related field required.
• 8+ years of epidemiology experience in pharma, biotech, academia, or public health, with a track record of leading observational research.
• Experience designing, executing and interpreting observational research and real-world evidence studies supporting regulatory, development, safety or commercial objectives, including strategic planning for post-approval/Phase 4 evidence generation and contribution to integrated evidence plans.
• Strong knowledge of epidemiological study design (cohort, case-control, registry-based) and real-world data sources.
• Working knowledge of immune-mediated disease epidemiology and outcome measurement is not required but is a meaningful advantage in this role.
• Proficiency in interpreting analyses from real-world data sources such as electronic health records, claims, registries and linked datasets; familiarity with statistical software (SAS, R, or similar) for epidemiological analysis.
• Understanding of pharmacoepidemiology methods, bias, and confounding control approaches.
• Understanding of the compliance boundaries governing Medical Affairs interaction with Commercial, including non-promotional communication of scientific data on an investigational product and applicable industry codes.
• Knowledge of regulatory frameworks governing real-world evidence use (e.g., FDA RWE guidance) and of payer/HTA evidence expectations (e.g., EUnetHTA/JCA, NICE, ICER).
• Proven ability to lead cross-functional scientific strategy and influence senior stakeholders.
• Ability to facilitate evidence gap assessment and prioritization across Clinical Development, Medical Affairs, HEOR/Market Access and Commercial, and to secure alignment on integrated evidence plans.
• Excellent scientific writing and presentation skills for regulatory, publication, and executive audiences.
• Ability to translate complex epidemiological findings for non-specialist stakeholders.
• Skilled at representing the company with external KOLs, regulators, and academic partners.