Assoc Director, Clinical Operations-Early Phase
Gilead Sciences
June 25, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Associate Director, Clinical Operations
Responsibilities:
- Lead execution of complex early-phase studies and/or multiple studies within a program, from planning through closeout.
- Provide operational oversight to ensure delivery against timelines, budgets, quality standards, and regulatory requirements.
- Drive program-level strategy (study design input, feasibility, risk mitigation, resource planning, execution planning).
- Accountable for study/program financial management (forecasting, budget oversight, resource allocation).
- Partner with Clinical Development, Clinical Pharmacology, Research, Regulatory, Biometrics, and other functions to deliver program objectives.
- Lead CRO/CRU/vendor selection, contract negotiations, and ongoing performance management.
- Influence decision-making using operational expertise and data-driven insights.
- Lead/contribute to transformation, change management, and continuous improvement initiatives.
- Serve as a subject matter expert or Business Process Owner for Clinical Operations processes, SOPs, tools, and systems.
- Identify risks and implement mitigation strategies.
- Ensure compliance with FDA, EMA, ICH-GCP, and internal SOPs.
- People manager (if applicable): lead/mentor/develop staff; coach and support career planning; set clear goals/accountability and remove operational barriers; oversee inspection readiness and support audits.
Basic Qualifications:
- Bachelor’s degree (or RN) with 10+ years relevant clinical research/life sciences experience, OR advanced degree with 8+ years relevant experience.
- Demonstrated experience leading complex clinical trials and/or programs.
- Strong knowledge of global clinical regulations (FDA/EMA), ICH-GCP, and clinical trial processes.
Preferred Qualifications:
- Early-phase clinical development experience; lead cross-functional teams; CRO/vendor sourcing/oversight; strategic thinking; process improvement/transformation experience; strong stakeholder management; ability to manage complexity/priorities; ability to travel as needed.
Benefits/Compensation:
- Salary range: $195,670.00 - $253,220.00; may be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application:
- For current employees/contractors: apply via Internal Career Opportunities portal in Workday.
Responsibilities:
- Lead execution of complex early-phase studies and/or multiple studies within a program, from planning through closeout.
- Provide operational oversight to ensure delivery against timelines, budgets, quality standards, and regulatory requirements.
- Drive program-level strategy (study design input, feasibility, risk mitigation, resource planning, execution planning).
- Accountable for study/program financial management (forecasting, budget oversight, resource allocation).
- Partner with Clinical Development, Clinical Pharmacology, Research, Regulatory, Biometrics, and other functions to deliver program objectives.
- Lead CRO/CRU/vendor selection, contract negotiations, and ongoing performance management.
- Influence decision-making using operational expertise and data-driven insights.
- Lead/contribute to transformation, change management, and continuous improvement initiatives.
- Serve as a subject matter expert or Business Process Owner for Clinical Operations processes, SOPs, tools, and systems.
- Identify risks and implement mitigation strategies.
- Ensure compliance with FDA, EMA, ICH-GCP, and internal SOPs.
- People manager (if applicable): lead/mentor/develop staff; coach and support career planning; set clear goals/accountability and remove operational barriers; oversee inspection readiness and support audits.
Basic Qualifications:
- Bachelor’s degree (or RN) with 10+ years relevant clinical research/life sciences experience, OR advanced degree with 8+ years relevant experience.
- Demonstrated experience leading complex clinical trials and/or programs.
- Strong knowledge of global clinical regulations (FDA/EMA), ICH-GCP, and clinical trial processes.
Preferred Qualifications:
- Early-phase clinical development experience; lead cross-functional teams; CRO/vendor sourcing/oversight; strategic thinking; process improvement/transformation experience; strong stakeholder management; ability to manage complexity/priorities; ability to travel as needed.
Benefits/Compensation:
- Salary range: $195,670.00 - $253,220.00; may be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application:
- For current employees/contractors: apply via Internal Career Opportunities portal in Workday.