Executive Director, Clinical Operations

Executive Director, Clinical Operations

Position Summary : The Executive Director, Clinical Operations will oversee the Clinical Trial team, including all clinical trial personnel. This role will act as liaison to the Data Management, QA, and CMC teams. This position will maintain effective communication with the team and all Clinical Operations service providers. The incumbent will work closely with the Clinical Program Management team, with CROs and clinical vendors to ensure that all assigned operational trial deliverables are met according to established timelines, budget, operational procedures, quality standards, SOPs and business guidelines.

Responsibilities :

• Provide recommendations and implement strategic milestones to ensure optimized clinical development plans for assigned projects
• Provide guidance to the Clinical Operations Leads to identify opportunities to optimize and streamline the delivery of clinical trials
• Provide direction and leadership in CRO and Vendor selection and management
• Establish external best practices and standards of working with Clinical Operations Service Providers including effective communication
• Oversee and participate in initial and Vendor Assessments, in collaboration with QA in conjunction with the Clinical Operations Leads and SMEs
• Partner closely with cross functional teams including Biostatistics, Data Management, Drug Safety, CMC and Supply Chain, Project Management and Regulatory to optimize operational excellence and improvements
• Build, manage, and cultivate high performing clinical teams and mentor new employees
• Create and manage the clinical operations budget and ensure clinical projects remain on schedule and within budget

Qualifications :