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 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
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