Director, Epidemiology

Job Description

The Real‑World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) department within the Clinical Development organization. We are seeking a Director, RWE Inflammation to contribute to the development and execution of the RWE strategy for an Inflammation product or products through development and commercialization. The incumbent will serve as an RWE subject‑matter expert for the product(s) on Gilead’s lifecycle management teams, including the Development Evidence Team (DET) and/or Early Molecule Teams (EMT).

The role partners with clinical development, medical, and commercial teams by generating RWE at the global level and designs and delivers RWE required by internal stakeholders and regulators. The Director, RWE Inflammation reports to the RWE Inflammation Product Lead.

• Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting clinical development and regulatory submissions for one or more pipeline/lifecycle indications for product(s) in Inflammation.
• Employ robust scientific methods and fit‑for‑purpose data to execute the RWE strategy in alignment with the clinical development plan and broader DET/EMT objectives.
• Generate a range of real‑world evidence studies, including natural history studies, population characterization, treatment pattern analyses, unmet need assessments, external comparator/control studies, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post‑authorization studies.
• Ensure fulfillment of observational study conduct and execution requirements such as study planning, operationalization, data sourcing, vendor oversight, data governance, registration, ethics/IRB review, protocol development, statistical analysis plan, study reporting, disclosure, and audit readiness.
• Communicate effectively about the utility of RWE across the product lifecycle and drive use of study and analysis results to support internal and external decisions.
• Contribute to timely development of epidemiological and RWE‑related components of regulatory deliverables for agencies worldwide, ensuring clear documentation, traceability, and alignment with internal governance and applicable data standards.
• Represent the RWE function in internal cross‑functional teams and initiatives.

• Doctoral degree (e.g., PhD, ScD) and/or Master’s degree (e.g., MSc, MPH) in Epidemiology from an accredited institution, with a minimum of eight (8) years of relevant, post‑graduation experience; preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry.
• Direct experience using RWE for regulatory‑facing evidence generation, such as supporting regulatory submissions, Health Authority interactions, or post‑authorization safety/effectiveness commitments.
• Experience designing and conducting observational research, including protocol, statistical analysis plan, and study report development, with comfort operating under regulatory‑grade documentation and compliance expectations.
• Experience with secondary data analysis using multi‑database real‑world data (e.g., EHR and/or medical claims) and familiarity with data collection approaches that complement RWD, including data tokenization, endpoint operationalization, and data quality assessment.
• Experience developing external comparators or external controls to support clinical development, including multi‑source data integration and prespecified endpoint definitions aligned to the trial.
• Working knowledge of clinical trial data standards and submission expectations, and experience partnering to translate RWD/RWE outputs into fit‑for‑purpose, well‑documented deliverables for internal governance or regulatory use.
• Demonstrated ability to operationalize complex observational studies in a regulated environment, including vendor oversight, privacy/security considerations, data provenance, SOP/working instruction development, and cross‑functional governance.
• A track record of scientific publications demonstrating expertise in observational study design, analysis, and…