Gilead Sciences · 8 hours ago
Executive Director, Clinical Development (Pediatrics)
San Francisco Bay Area
Full-time
Hybrid
Director/Executive
$325K/yr - $420K/yr
8+ years expGilead Sciences is dedicated to creating a healthier world by developing therapies for various diseases. The Executive Director, Clinical Development, will oversee pediatric drug development, managing clinical trials and leading a team to ensure innovative medicines are tailored for children.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Strategic input and oversight for pediatric development programs
Oversee development and execution of Phase 1, 2, and 3 clinical trials and provide scientific expertise
Serve as a resource for pediatric drug development for Clinical Development and cross-functional areas
Liaise and engage between the pediatric teams and the Gilead Asset Teams and support the Pediatric Development Leads in engaging with the Development Evidence Teams
Leadership role in clinical strategy and execution of all pediatric virology programs including collaboration with Vice Presidents in Virology (Department Review Committee Chairs) and Development Evidence Leaders for molecules / products
Represents or oversee representation for the assigned molecules / products in cross-functional steering and /or governance committees
Manages direct reports as Pediatric Development Team Leaders to ensure clinical development project deliverables and timelines are consistently met
Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products
In general, provides oversight for communications, both written and oral, with health authorities
Oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents including pediatric investigation plans (PIPs) and pediatric study plans (PSPs)
Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations
Presents or oversees presentations of scientific information at scientific conferences as well as clinical study investigator meetings; where applicable, takes a lead on authoring scientific publications
Key insight and involvement in the evaluation of pediatric aspects of business development opportunities
Develops thought leader and other external relationships that can guide short- and long-range pediatric clinical development strategies and direction for multiple molecules, the disease or therapeutic area overall
Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs
Provides scientific and clinical guidance to Research, Biology, Virology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff, as applicable
May lead two or more specific components of organizational strategic initiatives
Qualification
Required
MD or equivalent with 8+ years' experience OR MS, PharmD or PhD in clinical research or clinical pharmacology with 14+ years' experience in drug development in the biopharma industry
Extensive experience leading high-complexity cross-functional drug development strategies and plans, including short- and long-range strategic planning, governance, and oversight
Extensive experience taking the lead on clinical study plans, protocol design, regulatory filings, clinical publications, and presentations
Understanding of Clinical Pharmacology/Clinical Pharmacokinetics principles and familiarity with using modeling and simulation to support pediatric drug development
Line management (direct reports) experience of at least 5+ years in drug development in the biopharma industry is required
Has an expert-level of knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans
Leadership experience with cross-functional organizations and strong EQ
Has thorough understanding of pharmaceutical regulatory requirements for pediatric drug development globally and impact on development and execution of clinical trials
Strong leadership skills with an ability to set vision, lead change, and mentor others
Ability to work effectively in a multidisciplinary, cross-functional team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution
Demonstrated ability to lead by influence and align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives
When needed, ability to travel 8-12 times a year both domestically and internationally (depending on final work location)
Preferred
Experience in pediatric drug development is strongly preferred; experience performing clinical research studies in HIV treatment or prevention, viral hepatitis, respiratory or other viral diseases is also an asset
Extensive experience interacting with and presenting to executives is strongly preferred
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
EIN Presswire
2026-02-02
2026-02-02
2026-01-23
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