Associate Director, Clinical Operations

Responsibilities

• Oversee clinical operational strategy, planning, and execution of global clinical trials
• Ensure internal and external teams deliver on time, within budget, and in compliance with GCP and ICH guidelines
• Draft and approve study-related plans, including Informed Consent Forms, CTAs, CRFs, and monitoring plans
• Manage CROs and strategic partners through governance, performance metrics, and risk management
• Drive financial accountability through budget management and resource utilization
• Oversee the maintenance and quality of the Trial Master File (TMF)
• Manage vendor contracts, change orders, and outsourcing strategies
• Mentor and provide guidance to CTMs, CRAs, and Clinical Operations team members
• Represent Clinical Operations on cross-functional study teams and governance meetings

Requirements

• Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas
• 10+ years of direct clinical trial management experience overseeing phase II/III international oncology clinical trials
• Ability to travel internationally to visit clinical sites and study meetings (up to 20%)

Preferred Qualifications

• Proven ability to solve problems and use clear judgment regarding regulatory requirements and complex clinical programs
• Excellent planning, leadership, communication, and negotiation skills
• Expert knowledge of the drug development process and ICH guidelines/GCP

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 the field of oncology.