Sr Director, Epidemiology
Gilead Sciences
2 months ago
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
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 an Inflammation product/program and its pipeline/lifecycle indications.
- Ensure use of robust scientific methods and fit-for-purpose data resources aligned with the clinical development plan and DET/EMT objectives.
- Provide functional perspective and subject-matter expertise on regulatory use of RWE as part of the product DET/EMT.
- Lead a team of observational research scientists to deliver proactive RWE generation (e.g., natural history, population characterization, treatment patterns/unmet need, external comparators, benchmarking clinical outcomes, comparative safety/effectiveness research, post-approval safety studies).
- Communicate and drive use of RWE study/analysis results across the product lifecycle for internal/external decisions.
- Oversee development of observational research content for regulatory documents, publications, and related materials.
- Oversee timely epidemiological sections of regulatory documents globally (e.g., Risk Management Plan, orphan/breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing materials).
- Represent RWE function in internal cross-functional and external organizations/workstreams.
- Collaborate with quantitative functions (Biostatistics, Bioinformatics) and with Research, Clinical Research, Medical Affairs, and Global Value & Access.
- Identify needs for processes or training gaps to improve efficiency, quality, and impact.
Requirements
- Doctoral degree in epidemiology with leadership experience (primary focus on epidemiology evidence generation for clinical development support, regulatory submission, and safety preferred).
- Strong publication record; observational study design/analysis/interpretation expertise; direct RWE experience for early-stage clinical development and regulatory approvals.
- Experience leading integrated RWE strategies aligned to development objectives.
- Strategic RWE leadership for regulatory filings/submissions; interactions with global health authorities; oversight supporting benefit–risk, labeling, and safety evaluations.
- Understanding of Inflammation therapeutic area (disease knowledge, treatment practice/guidelines, trial endpoints and safety outcomes).
- Experience leading/coaching/managing globally.
- High autonomy; cross-functional collaboration; ability to manage priorities/resources/performance in a changing environment.
- Proactive cross-functional communication; cross-cultural sensitivity.
Minimum Required Education and Experience
- Bachelor’s + 14 years OR Master’s + 12 years OR PhD + 12 years.
Preferred Education and Experience
- Doctoral and/or Master’s in Epidemiology; at least 12 years relevant post-graduation experience, with preference for at least 6 years in biopharmaceutical industry.
- Serve as single point of accountability for development, execution, and communication of the global RWE strategy supporting clinical development and regulatory submissions for an Inflammation product/program and its pipeline/lifecycle indications.
- Ensure use of robust scientific methods and fit-for-purpose data resources aligned with the clinical development plan and DET/EMT objectives.
- Provide functional perspective and subject-matter expertise on regulatory use of RWE as part of the product DET/EMT.
- Lead a team of observational research scientists to deliver proactive RWE generation (e.g., natural history, population characterization, treatment patterns/unmet need, external comparators, benchmarking clinical outcomes, comparative safety/effectiveness research, post-approval safety studies).
- Communicate and drive use of RWE study/analysis results across the product lifecycle for internal/external decisions.
- Oversee development of observational research content for regulatory documents, publications, and related materials.
- Oversee timely epidemiological sections of regulatory documents globally (e.g., Risk Management Plan, orphan/breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing materials).
- Represent RWE function in internal cross-functional and external organizations/workstreams.
- Collaborate with quantitative functions (Biostatistics, Bioinformatics) and with Research, Clinical Research, Medical Affairs, and Global Value & Access.
- Identify needs for processes or training gaps to improve efficiency, quality, and impact.
Requirements
- Doctoral degree in epidemiology with leadership experience (primary focus on epidemiology evidence generation for clinical development support, regulatory submission, and safety preferred).
- Strong publication record; observational study design/analysis/interpretation expertise; direct RWE experience for early-stage clinical development and regulatory approvals.
- Experience leading integrated RWE strategies aligned to development objectives.
- Strategic RWE leadership for regulatory filings/submissions; interactions with global health authorities; oversight supporting benefit–risk, labeling, and safety evaluations.
- Understanding of Inflammation therapeutic area (disease knowledge, treatment practice/guidelines, trial endpoints and safety outcomes).
- Experience leading/coaching/managing globally.
- High autonomy; cross-functional collaboration; ability to manage priorities/resources/performance in a changing environment.
- Proactive cross-functional communication; cross-cultural sensitivity.
Minimum Required Education and Experience
- Bachelor’s + 14 years OR Master’s + 12 years OR PhD + 12 years.
Preferred Education and Experience
- Doctoral and/or Master’s in Epidemiology; at least 12 years relevant post-graduation experience, with preference for at least 6 years in biopharmaceutical industry.