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
The expected salary range for this position based on the primary location of CA is $125,100.00 - $232,300.00 USD. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
