Senior Global Clinical Trial Leader

$148,300 - $275,300/Yr

Genentech - South San Francisco, CA

Full-time - Senior

South San Francisco, CA

Chemical Manufacturing

About the position

The Genentech Research and Early Development (gRED) Sr. Global Clinical Trial Leader (Sr. CTL) is a pivotal role responsible for the strategic planning, execution, and delivery of one or more early development global clinical trials. This position requires a seasoned leader who can drive study strategy and lead cross-functional global teams while managing overseas vendors. The Sr. CTL is expected to proactively manage risks and champion change, ensuring that complex programs focusing on the rapid development of new molecular entities are executed effectively, even in the absence of extensive clinical data. This necessitates the implementation of novel and highly flexible global operational strategies. In this role, you will lead cross-functional Protocol Execution Teams (PETs) through all stages of the study to achieve clinical development goals. You will inspire and influence teams to foster a positive and innovative work environment while promoting accountability both globally and locally. Your oversight will extend to critical clinical trial activities, including vendor management, drug supply, monitoring plans, and biomarker sample management. Collaboration with Clinical Science will be essential to provide operational input on protocol design, feasibility, and execution. You will play a key role in country and site selection, study-specific patient recruitment, and ensuring that study milestones are met on time. Additionally, you will manage the overall study budget and resources, identifying risks and developing mitigation strategies in collaboration with PET teams. Your leadership will contribute to operational expertise, process improvements, training, and strategic planning across gRED and Roche, making you an integral part of the clinical development process.

Responsibilities

• Lead cross-functional Protocol Execution Teams (PETs) through all study stages to achieve clinical development goals.
• Inspire and influence teams to foster a positive, innovative work environment and promote accountability globally and locally.
• Oversee critical clinical trial activities, including vendor management, drug supply, monitoring plans, and biomarker sample management.
• Collaborate with Clinical Science to provide operational input on protocol design, feasibility, and execution.
• Play a key role in country/site selection, study-specific patient recruitment, and ensuring study milestones are met on time.
• Manage overall study budget and resources, identifying risks and developing mitigation strategies with PET teams.
• Provide leadership in operational expertise, contributing to process improvements, training, and strategic planning across gRED and Roche.

Requirements

• Bachelor's degree or equivalent required (scientific or healthcare discipline preferred).
• 7+ years clinical and drug development experience; ideally 3+ years clinical trial management experience including leading and managing cross functional teams.
• Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.

Benefits

• Discretionary annual bonus based on individual and Company performance.