Global Clinical Trial Leader

Global Clinical Trial Leader

Global Clinical Trial Leader supporting a pharmaceutical company in South San Francisco, CA on a hybrid schedule. This role leads execution and delivery of early-phase global clinical trials (Phase III), partnering with cross-functional Protocol Execution Teams to drive timelines, vendor/CRO oversight, trial documentation (TMF/CTMS), and proactive risk mitigation to ensure high-quality study outcomes.

Responsibilities

• Provide operational guidance to global cross-functional Protocol Execution Teams (PETs) across all study stages, including start-up, conduct, and close-out.
• Foster a positive work environment built on mutual respect, innovation, and accountability at both local and global project levels.
• Drive and finalize cross-functional activities ensuring the quality delivery of vendor specifications, drug supply forecasting, monitoring/communication plans, Trial Master Files (TMF), and CTMS data.
• Collaborate with cross-functional members on study plans and coordinate effective investigator meetings.
• Participate in vendor selection alongside the PETL; oversee outsourced activities to ensure CROs and vendors deliver against contracted scopes of work.
• Provide strategic input into the overall study budget and directly manage assigned vendor budgets.
• Contribute to country and site selection, assist in developing clinical trial protocols/informed consents, and provide operational input on protocol feasibility.
• Apply critical thinking to manage timelines, identify bottlenecks, and propose resolutions.
• Maintain a patient and site-centric mindset across all trial activities.
• Partner with colleagues to establish operational best practices and enhance clinical trial execution.
• Serve as a Subject Matter Expert or single point of contact for functional initiatives.
• Coach, mentor, and share expertise to support junior staff and peers.

Requirements

• Bachelor's degree or equivalent in a scientific or healthcare discipline.
• 8+ years of clinical study management experience.
• Working knowledge of GCP/ICH requirements, international regulatory guidelines, and drug development processes.
• Some travel may be necessary.
• Proven experience managing delegated aspects of global, complex Phase I and II clinical studies.
• Success in managing a diverse portfolio of vendors and CROs.
• Adept at identifying, assessing, and mitigating operational risks using data.
• Excellent communication skills, with the ability to influence and negotiate with stakeholders.
• Creative problem solver in ambiguous situations.
• Highly flexible, solution-focused, exercising good judgment on guidance seeking.
• Advocates organizational change to positively impact the business.