Senior Director, Epidemiology

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.

• 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

• 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.

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired.

Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law.

A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices.

may include, but are not limited to:

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms.

Specific benefit details applicable to your country or region will be provided during the offer process.

Beeline Medicines is an Equal Opportunity Employer.

We celebrate diversity and are committed to creating an inclusive environment for all employees.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation.

We are committed to providing equal access to all candidates.

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