Executive Director, Study Support & Oversight

Key Responsibilities

• Manages team of Site Alliance Managers, Oversight Monitors and Clinical Trial Assistance in the execution of operational oversight and support across clinical studies to ensure consistent, high-quality trial execution
• Partner with study teams to monitor study progress, operational risks, timelines and key deliverables
• Support operational governance activities and escalation management across the clinical portfolio
• Ensure operational activities are conducted in alignment with protocol, SOPs, ICH-GCP and applicable regulatory requirements
• Contribute to the identification of operational risks and develop mitigation strategies to maintain study quality and delivery timelines
• Cover CRO & Vendor Oversight
• Contribute to the oversight and governance of CROs and external vendors supporting clinical studies
• Establish operational expectations, KPIs and performance management standards across external partners
• Review vendor metrics, deliverables and operational performance to ensure quality and execution expectations are met
• Attend vendor governance meetings, issue escalation discussions and operational review processes
• Support vendor selection, onboarding and partnership management activities
• Lead Clinical Operations Support Functions
• Lead SAM team to ensure accurate, real-time knowledge of site status
• Show measurable enrollment impact (Site enrollment vs target, screening-enrollment conversation)
• Ensure appropriate documentation and engagement cadence
• Attend meetings prepared with data for clinical sites
• Oversee operational support activities including study tracking, reporting, inspection readiness support, documentation oversight and process management
• Partner with Clinical Quality and study teams to ensure operational documentation is inspection-ready
• Support Trial Master File quality and operational compliance activities
• Help establish scalable support models, tools and operational infrastructure to support organizational growth
• Contribute to portfolio-level operational planning and resource coordination
• Cross-Functional Collaboration
• Partner closely with Clinical Development, Biometrics, Regulatory Affairs, Clinical Supply, Medical Writing and Clinical Quality to support integrated study execution
• Facilitate communication and alignment across internal stakeholders and external partners
• Support leadership visibility into study health, operational risks and delivery timelines
• Contribute operational expertise to study planning, governance and execution strategy discussions
• Operational Excellence & Process Improvement
• Identify opportunities to improve operational efficiency, consistency and scalability across Clinical Operations
• Support development and refinement of SOPs, templates, trackers and operational processes
• Champion a culture of accountability, collaboration and continuous improvement
• Mentor team members and contribute to development of operational best practices across the organization

Required Education And Experience

• Bachelor’s degree required; advanced scientific, healthcare or business degree preferred
• 12+ years of biotech/pharmaceutical clinical operations experience with increasing leadership responsibility
• Strong experience overseeing CROs, vendors and operational delivery within clinical development programs
• Experience supporting Phase 1–3 clinical trials within biotech, pharmaceutical or CRO environments
• Strong understanding of ICH-GCP, FDA regulations and clinical trial operational requirements
• Experience supporting inspection readiness and operational quality initiatives preferred
• 5+ years of prior leadership and /or team management experience