Director, Clinical Operations Study Start-Up

Responsibilities

• Provide strategic and operational leadership for end‑to‑end study start‑up activities across assigned clinical programs
• Lead multiple programs to ensure investigative sites are activated according to study timelines
• Oversee country- and site-level regulatory and ethics submissions (IRB/EC/HA)
• Partner with CROs to oversee site contract and budget negotiations
• Monitor vendor performance and participate in Vendor Governance
• Develop and maintain study start‑up processes, systems, and tools to reduce cycle times
• Manage and develop staff with potential financial accountabilities

Requirements

• Minimum BA/BS degree or relevant graduate degree
• 15+ years of experience in biotech/pharmaceutical industry
• Direct experience in feasibility, study start-up, and site activation for global Phase 3 clinical trials
• 5+ years of supervisory or management experience
• Deep understanding of ICH-GCP and global regulatory requirements
• Experience with eTMF, CTMS, and site payments
• Proven track record in clinical trial execution and operational strategy

About the Company

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs through clinical studies in oncology.