Global Early-Development Clinical Trial Lead

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

Benefits offered by this job

Hybrid schedule

Discretionary annual bonus

Job summary

Genentech in South San Francisco is seeking a Global Clinical Trial Leader (CTL) to oversee the operational execution and global delivery of early development trials (Phases I–II). You will lead cross-functional Protocol Execution Teams (PETs), drive critical deliverables, and ensure TMF quality and CTMS data integrity.

Ideal candidates hold a Bachelor’s degree, 4+ years in clinical study management, knowledge of ICH/GCP, and hands-on experience in global Phase I/II studies.

Qualifications

• Bachelor's degree or equivalent in scientific or healthcare field.
• 4+ years of clinical study management experience in biopharma or CRO environments.
• Strong working knowledge of ICH/GCP guidelines and regulatory frameworks.
• Hands-on experience managing operational aspects of global Phase I/II studies.
• Proven expertise in clinical trial execution and vendor oversight.

Responsibilities

• Provide clinical operational expertise across all study lifecycle phases to one or more global PETs.
• Drive and finalize critical trial deliverables including vendor specs, drug supply forecasting, monitoring plans, TMF quality, and CTMS data integrity.
• Collaborate with cross-functional teams to solicit input on study plans, feasibility assessments, and investigator meeting execution.
• Participate in vendor identification and selection and manage outsourced CRO activities within scope, timelines, and budgets.
• Contribute operational feasibility insights to protocol and ICF design, anticipating challenges in early trials.
• Monitor critical path milestones, identify risks, and propose mitigations and solutions to bottlenecks.
• Foster an inclusive, high-trust environment for reliable, high-quality delivery.

Skills

Clinical trial management

Cross-functional collaboration

Vendor oversight

ICH/GCP knowledge

Education

Bachelor's degree

Job description

Genentech in South San Francisco is seeking a Global Clinical Trial Leader (CTL) to oversee the operational execution and global delivery of early development trials (Phases I–II). You will lead cross-functional Protocol Execution Teams (PETs), drive critical deliverables, and ensure TMF quality and CTMS data integrity.

Ideal candidates hold a Bachelor’s degree, 4+ years in clinical study management, knowledge of ICH/GCP, and hands-on experience in global Phase I/II studies.