Global Clinical Trial Lead - Early Development (Ph I/II)

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

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.