Director, Epidemiology
Gilead Sciences
August 14, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Director, RWE Inflammation — Duties & Responsibilities:
- Serve as single point of accountability for development, execution, and communication of the global RWE strategy supporting clinical development and regulatory submissions for Inflammation product(s).
- Employ robust scientific methods and fit-for-purpose data aligned with the clinical development plan and DET/EMT objectives.
- Generate real-world evidence (natural history, population characterization, treatment patterns/unmet need, external comparators/controls incl. multi-database EHR/claims and chart review/abstraction, benchmarking outcomes, comparative safety/effectiveness research, post-authorization studies).
- Oversee observational study fulfillment: planning/operationalization (feasibility, data sourcing, vendor oversight, data governance), registration, ethics/IRB, protocol, statistical analysis plan (SAP), study reports, disclosure, and inspection/audit readiness.
- Communicate RWE utility across the product lifecycle and drive use of results for internal/external decisions.
- Contribute to epidemiological and RWE components of worldwide regulatory deliverables with clear documentation/traceability.
- Represent RWE function in internal cross-functional teams.
Requirements:
- Doctoral (PhD/ScD) and/or Master’s (MSc/MPH) in Epidemiology; min. 8 years relevant post-graduation experience (preference: min. 6 years in biopharma).
- Direct RWE experience for regulatory-facing evidence generation (submissions/label expansions, Health Authority interactions, post-authorization commitments).
- Experience designing and conducting observational research (protocol, SAP, study reports) under regulatory-grade compliance and traceability.
- Multi-database secondary data analysis experience (EHR/claims) and familiarity with chart review/abstraction; data tokenization, endpoint operationalization, data quality.
- Experience developing external comparators/external controls (external control trials/hybrid/synthetic arms) incl. multi-source integration and prespecified endpoints; partner engagement.
- Working knowledge of clinical trial data standards and translating RWD/RWE into well-documented deliverables (mapping/specs, metadata, traceability, quality checks).
- Ability to operationalize complex observational studies in regulated environments (vendor oversight, privacy/security, data provenance, SOPs, governance).
Preferred:
- Scientific publications demonstrating expertise in observational study design/analysis/interpretation.
People leader accountabilities:
- Create Inclusion; Develop Talent; Empower Teams.
Application:
- Apply via the Internal Career Opportunities portal in Workday.
- Serve as single point of accountability for development, execution, and communication of the global RWE strategy supporting clinical development and regulatory submissions for Inflammation product(s).
- Employ robust scientific methods and fit-for-purpose data aligned with the clinical development plan and DET/EMT objectives.
- Generate real-world evidence (natural history, population characterization, treatment patterns/unmet need, external comparators/controls incl. multi-database EHR/claims and chart review/abstraction, benchmarking outcomes, comparative safety/effectiveness research, post-authorization studies).
- Oversee observational study fulfillment: planning/operationalization (feasibility, data sourcing, vendor oversight, data governance), registration, ethics/IRB, protocol, statistical analysis plan (SAP), study reports, disclosure, and inspection/audit readiness.
- Communicate RWE utility across the product lifecycle and drive use of results for internal/external decisions.
- Contribute to epidemiological and RWE components of worldwide regulatory deliverables with clear documentation/traceability.
- Represent RWE function in internal cross-functional teams.
Requirements:
- Doctoral (PhD/ScD) and/or Master’s (MSc/MPH) in Epidemiology; min. 8 years relevant post-graduation experience (preference: min. 6 years in biopharma).
- Direct RWE experience for regulatory-facing evidence generation (submissions/label expansions, Health Authority interactions, post-authorization commitments).
- Experience designing and conducting observational research (protocol, SAP, study reports) under regulatory-grade compliance and traceability.
- Multi-database secondary data analysis experience (EHR/claims) and familiarity with chart review/abstraction; data tokenization, endpoint operationalization, data quality.
- Experience developing external comparators/external controls (external control trials/hybrid/synthetic arms) incl. multi-source integration and prespecified endpoints; partner engagement.
- Working knowledge of clinical trial data standards and translating RWD/RWE into well-documented deliverables (mapping/specs, metadata, traceability, quality checks).
- Ability to operationalize complex observational studies in regulated environments (vendor oversight, privacy/security, data provenance, SOPs, governance).
Preferred:
- Scientific publications demonstrating expertise in observational study design/analysis/interpretation.
People leader accountabilities:
- Create Inclusion; Develop Talent; Empower Teams.
Application:
- Apply via the Internal Career Opportunities portal in Workday.