Teams at Summit Therapeutics, Inc.

Leads global Phase II/III oncology clinical trials from startup through closeout, overseeing sites, CROs, enrollment, monitoring, data quality, TMF completeness, risk management, regulatory compliance, audits, and inspection readiness. Reviews study plans and clinical data, resolves operational risks, mentors clinical operations staff, and represents Clinical Operations on cross-functional governance teams.

Manages global Phase II/III clinical trials from site selection and study startup through closeout. Oversees CROs, site performance, enrollment, monitoring, clinical data quality, risk-based quality management, TMF completeness, regulatory compliance, and inspection readiness. Coordinates study plans and deliverables, resolves operational issues, reviews monitoring reports and data listings, and mentors clinical operations staff. Global oncology experience is preferred, with international travel of up to 20%.

Provides operational leadership for global Phase II/III oncology clinical trials, overseeing clinical operations teams, CROs, vendors, budgets, timelines, quality, and inspection readiness. Leads study planning and execution, risk mitigation, TMF oversight, regulatory inspection preparation, outsourcing strategy, and cross-functional collaboration. Manages and mentors CTMs, CRAs, and other clinical operations staff while driving process improvement and compliance with GCP, ICH guidelines, and applicable regulations.