Clinical Operations Director overseeing patient care in Oncology Clinics at Duke Health. Leading clinical management and strategic planning for Wake County Oncology Clinics.
SI
Hybrid Executive Director, Clinical Operations
Posted last week
About the role
- Executive Director, Clinical Operations at Summit Therapeutics leading global Phase III oncology clinical trials. Accountable for clinical trial delivery and managing a high-performing Clinical Operations organization.
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.
- Willingness to travel internationally as needed.
Benefits
- Bonuses
- Stock options
- Health insurance
- Professional development opportunities
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