Senior Clinical Operations Lead

About the Role Join Gilead's Clinical Operations as a Senior Clinical Operations Lead to oversee the worldwide execution of Phase I–IV trials, with a focus on Late Phase and Observational Research studies. This site-based role (Tuesday–Thursday) at the Foster City, CA campus ensures trials are conducted in accordance with SOPs, company policies and regulatory guidelines to deliver timely, high-quality data that supports global registrations. What You'll Do

• Manage a geographical region or multiple components of assigned clinical studies, including Late Phase and Observational Research studies.
• Actively manage study budgets and provide proactive financial oversight.
• Collaborate cross-functionally to achieve study goals and communicate with CROs, subcontractors and vendors to ensure project team goals are met.
• With guidance, lead CRO/vendor selection and train/oversee interactions and deliverables from CROs, subcontractors, and vendors.
• Serve as the key operational contact for Gilead studies, including site evaluation, initiation, close-out visits and monitoring visits.
• Define study logistics and oversee/develop clinical study plans; manage study timelines and communications.
• Participate in initiatives/projects and manage project meetings with CROs, vendors and cross-functional teams.
• Contribute to SOP development and/or participate in special projects; develop tools and processes to improve efficiencies.
• Provide input into study protocols, CRFs and informed consents; oversee/author study plans and presentations.
• Review data listings and prepare interim/final clinical study reports; may contribute to abstracts, presentations, and manuscripts.
• Ensure CROs/vendors comply with protocols, regulatory requirements, SOPs, and monitoring plans; oversee safety and reporting activities.
• Lead or assist in safety, interim and final study reports and resolve data discrepancies.
• Train new or less experienced colleagues; ensure adherence to established practices, policies and regulatory requirements.
• Travel as needed. What We're Looking For
• MA/MS/PharmD/PhD with 3+ years of relevant clinical or related experience in life sciences; or BA/BS/RN with 5+ years of relevant experience.
• Experience leading or managing complex studies and project teams; experience managing CROs and external vendors.
• Knowledge of FDA, EMEA, and other applicable national regulations, ICH guidelines, and GCPs; familiarity with study management tools.
• Ability to navigate a fast-paced, matrixed environment; strong communication and collaboration skills; ability to travel. Nice to Have
• Experience contributing to abstracts, presentations and manuscripts. Compensation & Benefits
• Salary: $146,540 - $189,640 USD per year.