Sr Clinical Trials Manager

Gilead Sciences • Foster City, CA

1d • $157,590 - $203,940 • Hybrid

About The Position

At Gilead, we are dedicated to creating a healthier world for all people. For over 35 years, we have been at the forefront of tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer, relentlessly working to develop therapies that improve lives and ensure global access. Our mission to combat the world's greatest health challenges requires collaboration, determination, and a passionate drive to make a difference. Every member of the Gilead team plays a crucial role in discovering and developing life-changing scientific innovations. We are seeking passionate and ambitious individuals ready to make a direct impact. As a people leader, you will be instrumental in evolving our culture and fostering an inclusive environment where every employee feels developed and empowered to achieve their aspirations. Join Gilead and help create the possible, together.

This role will focus on managing Collaborative (CO) and Investigator Initiated Research (IIR) programs across Gilead’s therapeutic areas. The ideal candidate will be a motivated, experienced, and talented individual capable of working independently, demonstrating effective leadership, and being an engaged team member in a dynamic, fast-paced environment. This is a hybrid office-based role, requiring three days per week in our Foster City, CA headquarters.

Requirements

• Bachelor's Degree and Six Years' Experience OR Master's Degree and Four Years' Experience.
• Strong interpersonal, communication, leadership, and influence skills.
• Comprehensive understanding of FDA/EMA regulations, ICH guidelines, GCP, and clinical operations principles.
• Knowledge of global pharmaceutical regulatory requirements and their impact on clinical trials.
• Excellent analytical, problem-solving, and organizational skills; ability to multitask and meet deadlines.
• Able to work independently and suggest solutions for project issues.
• Experience in managing staff as well as mentoring and developing junior staff is required.

Nice To Haves

• At least 8+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline.
• At least 6+ years of experience and a Masters' degree or higher; scientific discipline preferred.
• Experience in the review and oversight of Investigator Sponsored & Collaborative Research strongly preferred.
• Experience in Phase IV and non-interventional studies preferred.
• Prior Global or large affiliate experience in medical affairs activities preferred.
• Prior supervisory/leadership experience preferred.

Responsibilities

• Provide oversight of the IIR & CO portfolio for one or more therapeutic areas, potentially serving as a Global Therapeutic Area Liaison (TAL).
• Liaise regularly with stakeholders and understand the Medical Affairs structure.
• Understand the global structure, procedures, and geographic differences within Clinical Operations (Clin Ops), including variations in publication handling and cross-TA collaboration.
• Represent Medical Affairs Research Operations at governance meetings.
• Critically evaluate scientific proposals or protocols to identify logistical, regulatory, and safety implications, highlighting potential risks and proposing mitigations to governance committees.
• Maintain an overview of ongoing and planned studies, ensure appropriate resourcing, and act as an escalation point for study managers for issue resolution.
• Understand the rationale for financial variances within a Therapeutic Area (TA) and serve as a Medical Affairs Research Operations point of contact with the Finance team.
• Collaborate with the Medical Affairs Research leadership team to discuss potential process updates, simplifications, and standardizations.
• Provide leadership and support to Study Managers on Investigator Initiated Research (IIR) and Collaborative (CO) Studies, including fair market value assessment, feasibility, protocol review, drug forecasting and supply, contract milestone advice, tracking, and publication follow-up.
• Support Study Managers with issue escalation/resolution and resource planning.
• Establish strong partnerships with external investigators and collaborators, as well as internal stakeholders (e.g., Med Affairs, Reg Affairs, Development Business Ops, PVE, Clinical Supply Management) to ensure timely, efficient, and high-quality study management.
• Identify and share best practice opportunities across Therapeutic Areas and Gilead sites.
• Maintain a strong understanding of industry standards for CO and IIR studies and stay informed of new changes and developments impacting Medical Affairs Research.
• Lead departmental or interdepartmental strategic initiatives.
• Provide training to colleagues on process changes/improvements as needed.
• Manage staff, mentor, and develop junior staff.
• May contribute to company-sponsored Non-Interventional Studies (e.g., retrospective/prospective observational studies, patient registries, HCP/patient surveys).
• Create Inclusion by understanding the business value of diverse teams, modeling inclusion, and embedding diversity values in team management.
• Develop Talent by understanding employee skills, experience, aspirations, and potential, coaching them on performance and future potential, and ensuring they receive necessary feedback for growth.
• Empower Teams by connecting them to the organization's goals and objectives, holding them accountable, providing support to remove barriers, and connecting them to the broader ecosystem.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives (eligibility may vary based on role).
• Paid time off.
• A benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior