Senior Director, Epidemiology

About this role

About Beeline Medicines:

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

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…