Clinical Program Manager
$182,070–$235,620 year
HybridFoster City, California, United States
Job Summary
Oversee worldwide execution of Phase I-IV clinical trials across Gilead's therapeutic areas, ensuring adherence to SOPs, policies, and regulatory guidelines to support global product registration. Manage multiple studies within designated budgets and timelines, leading cross-functional Study Management Teams and influencing stakeholders on resource deployment and project adjustments. Provide financial oversight, oversee CRO/vendor selection through RFP development, and author study protocols and regulatory documentation while mitigating risks. Participate in organizational change initiatives, standardize Clinical Operations processes, and ensure team compliance with FDA, EMA, and ICH guidelines. This hybrid role requires three days on-site (Tuesday–Thursday) and involves travel.
Required Qualifications
- BA / BS / RN with 8 or more years' relevant clinical or related experience in life sciences
- MA / MS / PharmD / PhD with 6 or more years' relevant clinical or related experience in life sciences
- Minimum of 4 years' cross-functional study management or related leadership experience in life sciences
- Experience developing RFPs and selection and oversight/management of CROs or other vendors
- Proven ability to successfully start-up, manage and close-out clinical studies
- Proven ability to effectively author clinical study and regulatory documentation
- Ability to lead and influence programs, projects and/or initiatives
- Strong interpersonal skills and understanding of team dynamics
- Proven ability to work successfully in a team-oriented, highly matrixed environment
- Demonstrated effectiveness coaching, guiding and directing the work of others
- Demonstrated effectiveness in proactively managing change
- Strong communication and organizational skills
- As required, the ability to travel
- This is a Hybrid position, 3 days on-site (Tues -Thurs)
- Will not consider fully remote candidates
Desired Qualifications
- Advanced knowledge of one or more disease or therapeutic areas
- Complete knowledge of full cycle study management, from start-up to close-out
- Advanced knowledge of study management best practices and tools
- Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations
- Thorough knowledge of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines
- Thorough knowledge of Good Clinical Practice (GCP) governing the conduct of clinical studies
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