Global Clinical Trial Leader

The Opportunity

As a Global Clinical Trial Leader (CTL) within Genentech Research and Early Development (gRED), you will be accountable for the operational execution and global delivery of pioneering early development clinical trials (Phases I and II) under the leadership of the Senior CTL. In this role, you will contribute directly to the cross-functional Protocol Execution Team (PET), translating cutting-edge scientific discoveries into highly flexible, operational reality for molecular entities with limited or no prior clinical data.

• Provide clinical operational expertise across all study lifecycle phases (start-up, conduct, and close-out) to one or more global cross-functional Protocol Execution Teams (PETs).
• Drive and finalize critical trial deliverables, including vendor specifications, investigational product drug supply forecasting, monitoring plans, Trial Master File (TMF) quality, and Clinical Trial Management System (CTMS) data integrity.
• Collaborate with and influence multidisciplinary cross-functional study teams to solicit strategic input on study plans, country/site feasibility assessments, and investigator meeting execution.
• Participate in vendor identification and selection alongside the PET Leader, managing delegated outsourced CRO activities to ensure deliverables align strictly with contracted scope, timelines, and budgets.
• Contribute operational feasibility insight to the clinical protocol and informed consent document (ICF) design, anticipating operational challenges unique to early-stage human trials.
• Monitor critical path study milestones, proactively identifying study risks, implementing mitigation plans, and proposing innovative resolutions to complex trial bottlenecks.
• Foster an inclusive, high-trust, and accountable project environment across local and global cross-functional partners to ensure reliable, high-quality clinical trial delivery.

Who you are

• Hold a Bachelor's degree or equivalent (scientific or healthcare discipline preferred).
• Bring 4+ years of clinical study management experience within biopharma or CRO environments.
• Demonstrate working knowledge of ICH/GCP guidelines, international regulatory frameworks, and early clinical drug development processes.
• Possess hands-on experience managing operational aspects of complex, global Phase I or Phase II clinical studies.
• Display proven expertise in clinical trial execution, cross-functional team collaboration, and study vendor oversight.

Preferred

• Direct experience operating within oncology, immunology, infectious disease, or neuroscience early-phase clinical development.
• Demonstrated track record managing specialized vendors (central labs, specialty bioanalytical labs, imaging, interactive response technology/IRT) and decentralized/digital trial technologies.
• Proven ability to thrive in ambiguous, fast-paced environments requiring adaptive study designs and rapid protocol amendments.

Location

• This role is based in South San Francisco and offers a hybrid schedule working 3 day per week on campus
• Relocation benefits are not available for this job posting