Senior Director, Epidemiology

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 expectatio