Senior Director, Clinical Operations – Oncology Trials

Summit Therapeutics, Inc.; Miami (FL); On-site; USD 170,000 - 198,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an Associate Director, Clinical Operations in Miami, FL to provide operational leadership for global oncology trials.

The role drives study delivery through cross-functional collaboration, risk management, and vendor oversight to ensure on-time, within-budget execution and inspection readiness. The ideal candidate has 10+ years of direct clinical trial management in phase II/III oncology, strong knowledge of GCP/ICH, and willingness to travel internationally

Qualifications

• 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 trials.
• Ability to travel internationally (up to 20%)

Responsibilities

• Oversee clinical operational strategy, planning, and execution of global trials.
• Ensure internal and external teams deliver on time, within budget and in compliance with GCP/ICH.
• Draft and approve study-related plans, documents including ICFs, CTAs, CRFs, and monitoring plans.
• Manage CROs, vendors, and partners with governance and risk management.
• Identify operational risks and implement proactive mitigation strategies.
• Drive budget management and resource utilization for trials.
• Maintain TMF quality and readiness for inspections.
• Oversee vendor contracts and outsourcing strategies with ROI focus.
• Collaborate with Finance on cost oversight and prudent vendor decisions.
• Support regulatory inspections and inspection readiness.
• Mentor CTMs, CRAs, and other Clinical Operations staff.
• Lead continuous improvements in Clinical Operations processes and standards.
• Represent Clinical Operations in cross-functional teams and governance.
• Foster collaboration with Regulatory, Data Management, Biostatistics, Pharmacovigilance, QA, CMC, and Commercial teams.

Skills

Clinical operations leadership

Vendor management

Cross-functional collaboration

GCP/ICH knowledge

Travel readiness

Education

Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical field

Tools

CTMS

Job description

Summit Therapeutics Inc. is seeking an Associate Director, Clinical Operations in Miami, FL to provide operational leadership for global oncology trials.

The role drives study delivery through cross-functional collaboration, risk management, and vendor oversight to ensure on-time, within-budget execution and inspection readiness. The ideal candidate has 10+ years of direct clinical trial management in phase II/III oncology, strong knowledge of GCP/ICH, and willingness to travel internationally