Hybrid Executive Director – Clinical Operations

at Summit Therapeutics, Inc.

• Job title: Executive Director – Clinical Operations
• Job type: Full Time
• Experience level: Lead
• Salary: $245,000 - $307,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Princeton, United States

About the role

• Executive Director leading global execution of multiple Phase III clinical trials in oncology at Summit Therapeutics. Building and mentoring a high-performing Clinical Operations organization within a fast-paced biotech startup.

Responsibilities

• Lead global execution of multiple Phase IIIII clinical trials in oncology (non-lung)
• Build, manage, mentor, and provide line management for Clinical Operations staff (>20 members with skip reports), including study management team leaders, clinical trial managers, CRAs and contractors
• Directly manage the global Study Start-Up team, overseeing essential documents, site budgets, and site contract negotiations
• Establish and drive SSU performance metrics, including site activation cycle times, essential document completeness, and budget and contract turnaround time
• Monitor progress, enrollment, quality, timelines, and budgets across multiple concurrent studies; proactively manage risks
• Timely escalation of risks to the Head of Clinical Operations.
• Lead CRO governance, including selection, contracting, performance monitoring, KPIs, risk management, escalation pathways, and executive reviews to ensure quality, timelines, and budget adherence
• Manage and oversee Randstad Services providing unblinding monitoring support, ensuring compliance, quality, timelines, and clear separation of blinded and unblinded activities
• Partner cross-functionally with Clinical Development, Medical Affairs, Regulatory, Biometrics, Safety, CMC, Quality, and Project Management across regions
• Support SOP development, review, and implementation to ensure consistency, compliance, and inspection readiness across clinical operations
• Support preparation of clinical components for global regulatory submissions and health authority inspections
• Implement fit-for-purpose global clinical operations processes, metrics, and oversight models appropriate for a growing biotech company
• Partner with Business Operations and IT to identify and implement technological solutions to replace manual processes and improve data transparency.
• All other duties as assigned

Requirements

• Bachelors degree in life sciences (advanced degree preferred)
• Minimum of 15+ years of clinical operations expertise spanning biotech, pharma, and CRO organizations, with the last decade dedicated to overseeing complex phase III oncology trials from startup through completion
• Proven track record of successfully managing direct reports and leading cross-functional teams through influence in a matrixed environment
• Demonstrated leadership over the last decade by managing teams exceeding 20 direct and skip-level reports, driving performance, development, and organizational alignment.
• Proven leadership of multiple global Phase IIIII trials
• Strong experience in CRO governance, including oversight frameworks, KPIs, risk escalation, and quality monitoring
• Experience overseeing unblinded monitoring models and external service providers
• Experience in SOP development, review, and implementation
• Deep knowledge of ICH, GCP, and global clinical trial regulations
• Strong experience with site budgets, contracts, CRO oversight, and vendor management
• Ability to operate strategically while remaining hands-on and execution-focused
• Demonstrated experience in process improvement and the application of technology to streamline clinical operations.

Benefits

• The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
• Paid time off
• Flexible work hours