Director, Clinical Development (MD)
Gilead Sciences
4 hours ago
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Responsibilities:
- Provide clinical leadership and input on HIV clinical studies; lead/assist multiple components of Phase 1–4 HIV clinical trial programs.
- Help design, conduct, and evaluate Phase 1–4 clinical trials; provide expertise in clinical hepatitis.
- Collaborate on trial implementation activities (including medical monitoring), data analysis/reporting, and support regulatory filings.
- Lead/submit clinical protocol design, clinical study reports, and responses to health authority inquiries.
- Manage preparation/review of regulatory documents, investigator brochures, development plans, IND annual/safety reports.
- Coordinate collection/assimilation of ongoing data and manage preparation/review of data listings, summary tables, study results, and scientific presentations.
- Present scientific information at conferences and investigator meetings; provide high-level guidance to cross-functional teams.
Basic Qualifications:
- 12+ years with BS/BA OR 10+ years with MS/MA or MBA.
Preferred Qualifications:
- MD/DO with 4+ years industry experience (clinical/biotech/pharma) with proven clinical research success; or PharmD/PhD with 8+ years drug development experience.
- HIV experience; cross-functional global development team experience; lead role in study concept/protocol design, regulatory filings, publications, and presentations.
- Knowledge of FDA/EMA regulations, ICH guidelines, GCP; strong analytical, communication, organization skills; travel when needed.
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.
- Provide clinical leadership and input on HIV clinical studies; lead/assist multiple components of Phase 1–4 HIV clinical trial programs.
- Help design, conduct, and evaluate Phase 1–4 clinical trials; provide expertise in clinical hepatitis.
- Collaborate on trial implementation activities (including medical monitoring), data analysis/reporting, and support regulatory filings.
- Lead/submit clinical protocol design, clinical study reports, and responses to health authority inquiries.
- Manage preparation/review of regulatory documents, investigator brochures, development plans, IND annual/safety reports.
- Coordinate collection/assimilation of ongoing data and manage preparation/review of data listings, summary tables, study results, and scientific presentations.
- Present scientific information at conferences and investigator meetings; provide high-level guidance to cross-functional teams.
Basic Qualifications:
- 12+ years with BS/BA OR 10+ years with MS/MA or MBA.
Preferred Qualifications:
- MD/DO with 4+ years industry experience (clinical/biotech/pharma) with proven clinical research success; or PharmD/PhD with 8+ years drug development experience.
- HIV experience; cross-functional global development team experience; lead role in study concept/protocol design, regulatory filings, publications, and presentations.
- Knowledge of FDA/EMA regulations, ICH guidelines, GCP; strong analytical, communication, organization skills; travel when needed.
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.