Global Clinical Trial Leader

Roche; South San Francisco (CA); Hybrid; USD 125,000 - 232,000; Full time

Job summary

Genentech, based in South San Francisco, is seeking a Global Clinical Trial Leader to drive operational execution for Phase I/II trials in a hybrid model (3 days on campus). You will lead cross-functional PETs, manage vendors, and ensure data integrity across CTMS and TMF processes.

The role requires 4+ years in clinical study management, ICH/GCP expertise, and a proven ability to oversee global studies in biopharma or CRO settings.

Qualifications

• Bachelor’s degree or equivalent in a scientific or healthcare discipline.
• 4+ years of clinical study management experience in biopharma or CRO.
• Working knowledge of ICH/GCP guidelines and regulatory frameworks.
• Hands-on experience managing operational aspects of global Phase I or II studies.
• Proven ability to lead cross-functional teams and oversee vendors.

Responsibilities

• Provide clinical operational expertise across all study lifecycle phases to global Protocol Execution Teams (PETs).
• Drive and finalize trial deliverables including vendor specs, drug supply forecasting, monitoring plans, TMF quality, and CTMS data integrity.
• Collaborate with cross-functional teams to gather input on study plans, country/site feasibility, and investigator meetings.
• Participate in vendor identification and selection and manage outsourced CRO activities.
• Contribute operational feasibility input to protocol and ICF design for early-stage trials.
• Monitor critical path milestones, identify risks, and implement mitigation plans.
• Foster an inclusive, high-trust environment with global partners to ensure high-quality trial delivery.

Skills

Clinical study mgmt

ICH/GCP knowledge

Cross-functional collaboration

Vendor oversight

Education

Bachelor’s degree or equivalent

Job description

Why Genentech

We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world’s most complex health challenges and transforming society.

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.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.