Sr Clinical Trials Manager
Gilead Sciences
Summary
Clinical Operations leads the global execution of Phase I–IV clinical trials across therapeutic areas, ensuring studies are conducted in compliance with SOPs, company policies, and regulatory requirements while delivering timely, high-quality data to support registration and commercialization. The Senior Clinical Trials Manager leads studies within a program, provides direction to Clinical Operations team members, and is accountable for execution against timelines, budgets, and quality standards. This role develops study operational strategies and may contribute to cross-functional or organizational initiatives. This is a Hybrid position, 3 days on-site (Tues -Thurs). Will not consider fully remote candidates.
Job description
Responsibilities
- Lead all aspects of assigned clinical studies within a program, including Study Management Team leadership as applicable.
- Develop, implement, and oversee study plans, timelines, logistics, budgets, and resourcing.
- Ensure studies are delivered on time, within budget, and in alignment with quality, protocol, SOP, and regulatory requirements.
- Identify study risks and proactively drive mitigation and issue-resolution strategies.
- Lead CRO and vendor selection, oversight, deliverable management, and relationship management as applicable.
- Partner with cross-functional stakeholders to align on study objectives, priorities, timelines, and deliverables.
- Provide guidance, training, and direction to internal team members, CROs, vendors, and investigators.
- Mentor and support the development of less experienced colleagues.
- Contribute to process improvement, standardization, operational excellence, and departmental initiatives.
Basic qualifications
- BA/BS with 6+ years of relevant clinical or related life sciences experience; or MA/MS with 4+ years of relevant clinical or related life sciences experience.
- Comprehensive knowledge of FDA, EMA, other applicable national regulations, ICH guidelines, and GCP requirements governing clinical studies.
Preferred qualifications
- Advanced degree such as MA/MS, PharmD, or PhD in a life sciences or related field.
- Experience leading clinical studies and cross-functional project teams.
- Demonstrated ability to lead teams, coach, and mentor less experienced colleagues.
- Clear, concise communication skills and strong interpersonal effectiveness.
- Proven ability to work successfully in a team-oriented, highly matrixed environment.
- Strong knowledge of full-cycle study management, from start-up through close-out.
- Advanced knowledge of study management best practices and tools, with demonstrated ability to improve study efficiency and effectiveness.
- Ability to travel as needed.
Requirements
- BA/BS with 6+ years of relevant clinical or related life sciences experience; or MA/MS with 4+ years of relevant clinical or related life sciences experience.
- Comprehensive knowledge of FDA, EMA, other applicable national regulations, ICH guidelines, and GCP requirements governing clinical studies.
- Advanced degree such as MA/MS, PharmD, or PhD in a life sciences or related field.
- Experience leading clinical studies and cross-functional project teams.
- Demonstrated ability to lead teams, coach, and mentor less experienced colleagues.
- Clear, concise communication skills and strong interpersonal effectiveness.
- Proven ability to work successfully in a team-oriented, highly matrixed environment.
- Strong knowledge of full-cycle study management, from start-up through close-out.
- Advanced knowledge of study management best practices and tools, with demonstrated ability to improve study efficiency and effectiveness.
- Ability to travel as needed.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Paid time off
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
Company overview
Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.