Responsibilities:
- Own development, execution, and communication of the global RWE strategy for an Inflammation product/program and its lifecycle indications, supporting clinical development and regulatory submissions.
- Ensure robust scientific methods and fit-for-purpose data resources; align with clinical development plan and DET/EMT objectives.
- Serve as regulatory RWE subject-matter expert within product DET/EMT.
- 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, post-approval safety studies).
- Drive use of RWE results across the product lifecycle; develop regulatory document sections and disseminate findings (publications/white papers/press releases).
- Oversee epidemiological sections of regulatory documents worldwide (e.g., RMP, orphan/breakthrough designations, PIP, query responses, advisory committee materials).
- Represent RWE in cross-functional initiatives and external organizations; collaborate with Biostatistics/Bioinformatics, Research, Clinical Research, Medical Affairs, and Global Value & Access.
- Identify process/training gaps to improve efficiency, quality, and impact.
Minimum Requirements:
- Bachelorโs + 14 years OR Masterโs + 12 years OR PhD + 12 years experience.
Preferred Qualifications/Skills:
- Epidemiology PhD/Masterโs with 12+ years relevant experience (prefer 6+ in biopharma); leadership in epidemiology evidence generation.
- Publications; expertise in observational design/analysis/interpretation and RWE applications (early development and regulatory).
- Experience leading integrated RWE strategies; strategic regulatory RWE leadership with global health authorities.
- Inflammation therapeutic area understanding; global people leadership; autonomy; cross-functional collaboration; priority/resource management; proactive communication; cross-cultural sensitivity.
Compensation/Benefits (if applicable):
- Bay Area: $261,375โ$338,250; Other US: $237,575โ$307,450. May include bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life.
Application Instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.