Senior Clinical Trials Manager - Hybrid Study Leader

Regulatory Jobs; Foster City (CA); Hybrid; USD 158,000 - 204,000; Full time

Benefits offered by this job

Bonus program

Stock incentives

Paid time off

Benefits package

Job summary

Gilead Sciences Inc. in Foster City seeks a Senior Clinical Trials Manager to lead Phase I–IV studies, ensure compliance with SOPs and regulatory requirements, and deliver high-quality data for registration and commercialization. This hybrid role requires 3 days on-site (Tue–Thu) and collaboration across Clinical Operations.

The position emphasizes study planning, cross-functional leadership, risk mitigation, and vendor management to support timely program delivery and quality data generation.

Qualifications

• BA/BS with 6+ years of clinical or life sciences experience; or MA/MS with 4+ years.
• Comprehensive knowledge of FDA, EMA, ICH guidelines, and GCP requirements governing clinical studies.

Responsibilities

• Lead all aspects of assigned clinical studies within a program and lead Study Management Team as applicable.
• Develop, implement, and oversee study plans, timelines, budgets, and resourcing.
• Ensure studies are delivered on time, within budget, and in compliance with quality, protocol, SOP, and regulatory requirements.
• Identify study risks and 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.

Skills

Clinical operations

Budget management

Cross-functional leadership

Regulatory compliance

Vendor management

Education

BA/BS with 6+ years life sciences

MA/MS with 4+ years life sciences

Job description

Gilead Sciences Inc. in Foster City seeks a Senior Clinical Trials Manager to lead Phase I–IV studies, ensure compliance with SOPs and regulatory requirements, and deliver high-quality data for registration and commercialization. This hybrid role requires 3 days on-site (Tue–Thu) and collaboration across Clinical Operations.

The position emphasizes study planning, cross-functional leadership, risk mitigation, and vendor management to support timely program delivery and quality data generation.