Vice President Clinical Operations

Qualifications

• Bachelor’s degree within a scientific discipline; advanced degree (MS/RN/PharmD) preferred.
• 15+ years’ experience in Clinical Operations; with at least 5 years in biotechnology preferred.
• Strong preference for experience in AAV gene therapy and/or Ophthalmology (retina).
• Expert level of knowledge within clinical operations, clinical development, and clinical project management.
• Demonstrated success in leading clinical operation teams for early and late-stage clinical development programs.
• In-depth knowledge of all aspects of CRO management and clinical trial audit activities.
• Demonstrated ability to effectively communicate clinical execution milestones, risks, and strategic pivots.
• Demonstrated ability to cultivate a mission-driven culture of high accountability, scientific integrity, and patient-centricity, ensuring that organizational values are deeply embedded across internal teams and external vendor partnerships.

Formula for Success

• Leverage a 'get it done' mindset and strong sense of ownership and accountability.
• Provide operational direction for outsourcing, selection, and oversight of CROs and provide ongoing executive management to selected partners.
• Develop and continuously monitor study timelines, study progress, study costs, and resource allocations.
• Implement corrective action when deviations occur; work with functions to develop contingency plans and drive their implementation when triggered.
• Oversee the preparation and management of clinical trial budgets.
• Serve as the Clinical Operations leader for internal governance meetings including cross-functional Project Team and Protocol Review Committee; effectively communicate clinical execution milestones, risks and strategic pivots.
• Interact collaboratively with Quality, Regulatory, CMC, Finance, and Clinical teams to ensure operational excellence in clinical trial execution to ensure compliance with GCP and ICH guidelines and financial reporting requirements.
• Lead long-range workforce planning, forecasting future hiring needs to scale the clinical operations team effectively as the pipeline expands.
• Lead, mentor, and develop a high-performing team focusing on professional growth, coaching, and succession planning.