Global Clinical Operations Lead – Oncology Trials

Summit Therapeutics, Inc.; Palo Alto (CA); On-site; USD 170,000 - 198,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an Associate Director, Clinical Operations to lead trial execution across global oncology programs. You will oversee cross-functional teams, vendor performance, and risk management to ensure on-time, quality study delivery.

The role requires strategic leadership, strong budget oversight, and deep knowledge of ICH/GCP guidelines, with travel up to 20% for global sites and meetings.

Qualifications

• 10+ years of direct clinical trial management experience in oncology.
• Experience overseeing phase II/III international trials.
• Willingness to travel internationally up to 20%.

Responsibilities

• Oversees the clinical operational strategy, planning, and execution of global trials.
• Ensures internal and external teams deliver on time, within budget, and compliant with GCP/ICH.
• Drafts study-related plans and documents (IC Forms, CTAs, CRFs, PK/PD analyses, monitoring plans).
• Manages CROs, vendors, and partners with governance and risk management.
• Identifies operational risks early and implements mitigation strategies.
• Drives financial accountability through budget management and resource use.
• Oversees TMF maintenance and quality reviews.
• Manages CRO proposals, contracts, and outsourcing strategies for value.
• Partners with Finance for cost oversight and prudent decisions.
• Prepares for regulatory inspections and supports inspection readiness.
• Mentors CTMs, CRAs, and clinical operations staff.
• Drives process improvements and standards in Clinical Operations.
• Represents operations in cross-functional study teams and governance.
• Fosters collaboration with Regulatory, Data Management, Biostatistics, QA, CMC, and Commercial.
• All other duties as assigned.

Skills

Leadership

Cross-functional collaboration

Budget management

Vendor management

Risk management

Education

Bachelor's degree in life sciences or related field

Tools

CTMS

TMF systems

Job description

Summit Therapeutics Inc. is seeking an Associate Director, Clinical Operations to lead trial execution across global oncology programs. You will oversee cross-functional teams, vendor performance, and risk management to ensure on-time, quality study delivery.

The role requires strategic leadership, strong budget oversight, and deep knowledge of ICH/GCP guidelines, with travel up to 20% for global sites and meetings.