Summit Therapeutics, Inc. · 1 hour ago
Executive Director, Clinical Operations
Princeton, NJ
Full-time
Onsite
Director/Executive
$245K/yr - $307K/yr
15+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life through innovative clinical studies. They are seeking an Executive Director of Clinical Operations to lead global execution of multiple Phase II–III clinical trials in oncology, with responsibilities including managing clinical operations staff and overseeing study start-up teams.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Lead global execution of multiple Phase II–III 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
Qualification
Required
Bachelor's degree in life sciences
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 II–III 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
High-quality executor; ability to execute against goals and milestones with quality, precision, and speed
Ability to operate effectively in a fast-paced, resource-conscious global startup environment
Willingness to travel internationally as needed
Preferred
advanced degree preferred
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Board Member
Recent News
2025-12-09
2025-12-05
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