Responsibilities:
- Single point of accountability for development, execution, and communication of the global RWE strategy for an Inflammation product/program and its pipeline/lifecycle indications.
- Ensure robust scientific methods and fit-for-purpose data resources aligned to clinical development and DET/EMT objectives.
- Serve as RWE subject-matter expert within product DET/EMT, especially for regulatory use of RWE.
- Lead observational research scientists to deliver proactive RWE generation (e.g., natural history, population characterization, treatment patterns/unmet need, external comparators, outcome benchmarking, comparative safety/effectiveness, and post-approval safety studies).
- Communicate RWE utility across the product lifecycle and drive internal/external decisions based on study/analysis results.
- Oversee epidemiological content in regulatory documents worldwide (e.g., Risk Management Plan, orphan/breakthrough, Pediatric Investigation Plan, query responses, advisory committee materials).
- Represent RWE in cross-functional initiatives and external organizations; foster collaborations with biostatistics/bioinformatics, Research, Clinical Research, Medical Affairs, and Global Value & Access.
Requirements:
- Doctoral degree in epidemiology with leadership experience (preferred focus on epidemiology evidence generation for clinical development, regulatory submissions, and safety).
- Publications and observational study design/analysis/interpretation; direct RWE experience in early-stage development and regulatory approvals.
- Proven experience leading integrated RWE strategies aligned to development objectives.
- Strategic RWE leadership for regulatory filings and interactions with global health authorities.
- Inflammation therapeutic area knowledge (disease, treatment practice/guidelines, endpoints, safety outcomes).
- Experience leading/coaching/managing globally; autonomy, cross-functional collaboration, priority/resource/performance management, and proactive communication.
- Well-developed cross-cultural sensitivity.
Minimum Experience:
- Bachelorโs + 14 years OR Masterโs + 12 years OR PhD + 12 years.
Preferred:
- Doctoral and/or Masterโs in Epidemiology; 12+ years relevant post-graduation experience (prefer 6+ in biopharma).
People Leader Accountabilities:
- Create Inclusion; Develop Talent; Empower Teams.
Benefits/Compensation:
- Bay Area salary range: $261,375โ$338,250; Other US locations: $237,575โ$307,450. Eligible for bonus, stock-based long-term incentives (role-dependent), paid time off, and medical/dental/vision/life insurance.
Application instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.