Clinical Trials Manager- Late Phase Oncology

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. Our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite, driving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations.

About the role

This role will be based out of our Foster City, California or Parsippany, NJ location. We are seeking a Clinical Trials Manager (CTM) to support the Oncology pipeline. The CTM drives end-to-end operational delivery of Phase II and III oncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight. This role serves as a key contributor for study execution and study management by coordinating with internal teams and external partners (including CROs and vendors), ensuring alignment across all stakeholders to achieve study objectives. The CTM applies strong project management, clinical, and regulatory expertise to proactively identify risks, implement solutions, and maintain study timelines to meet deliverables for in-house and/or hybrid model clinical trials.

Responsibilities

• Coordinate and supervise all aspects of clinical study.
• Assist Clinical Program Manager in overall study management.
• Provide input into study protocols, investigator brochures, case report forms, informed consents, final study reports, oversee/author study plans, and presentations.
• Maintain study timelines, including documentation and communications.
• Contribute to development of study budget.
• Contribute to development of RFPs and participate in selection of CROs/vendors.
• Manage CROs/vendors or functional service providers.
• Serve as the key operational contact for Gilead studies, providing oversight for site evaluation, initiation, and close-out visits, as well as conducting oversight monitoring visits.
• Provide oversight of study sites/region and review routine regulatory documents to ensure compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
• Ensure effectiveness of site budget/contract process.
• Train CROs, vendors, investigators, and study coordinators on study requirements as needed.
• Coordinate review of data listings and preparation of interim/final clinical study reports and appendices, including resolving data discrepancies.
• Assist in determining activities to support a project’s priorities within functional area.
• Develop tools and processes that optimize project efficiencies and effectiveness.
• Travel is required.

Requirements

• Prior Oncology experience and prior CRO/Pharma/Biotech experience is required.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Ability to understand, interpret, and explain protocol requirements to others.
• Ability to prioritize multiple tasks.
• May serve as a resource for others within the company for clinical trials management expertise.
• Under general supervision, examine functional issues from an organizational perspective.
• General, functional expertise to support SOP development and implementation.

Qualifications

• 5+ years with BS/BA in a relevant scientific discipline.
• 3+ years with MS/MA in a relevant scientific discipline.

People Leader Accountabilities

• Create Inclusion: Know the business value of diverse teams, model inclusion, and embed the value of diversity in the way you manage your teams.
• Develop Talent: Understand the skills, experience, aspirations, and potential of your employees and coach them on current performance and future potential. Ensure employees receive the feedback and insight needed to grow and develop.
• Empower Teams: Connect the team to the organization by aligning goals, purpose, and organizational objectives, and hold them accountable. Provide the support needed to remove barriers and connect your team to the broader ecosystem.

Pay

The salary range for this position is:

• Bay Area: $146,540.00 - $189,640.00
• Other US Locations: $133,195.00 - $172,370.00

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit Gilead Benefits.