VP, Clinical Operations, Data Management

Key Elements and Responsibilities

• Provide strategic and operational leadership for clinical operations and data management across programs, from study start-up through close-out, in compliance with ICH-GCP.
• Ensure the quality, integrity, and inspection-readiness of all clinical and data management activities globally.
• Drive cross-functional collaboration to deliver clinical trials on time and within budget.
• Lead planning, execution, and reporting of clinical studies, ensuring alignment on timelines, deliverables, and resources.
• Act as the primary escalation point for critical study and vendor issues.
• Oversee study budgets, timelines, resources, and financial tracking.
• Partner with Clinical Science, Biostatistics, and external vendors to ensure seamless delivery of:
  • Clinical documentation
  • Data management activities
• Ensure effective coordination of regulatory submissions (e.g., IRB/ethics committees, local authorities).
• Oversee data management strategy and execution, including database design, build, maintenance, and database lock activities, in alignment with biostatistics.
• Ensure robust data integrity, accurate record-keeping, and compliant archiving practices.
• Provide oversight of clinical sites, academic partners, and vendors (e.g., CROs, labs) to ensure performance, quality, and compliance.
• Build and maintain strong relationships with investigators and key opinion leaders.
• Lead, develop, and mentor high-performing teams.
• Ensure delivery of high-quality study documentation to meet program timelines.

Requirements

• Experience, Skills & Knowledge
• Extensive experience in clinical operations leadership within biotech/pharma.
• Strong clinical project and program management expertise.
• Proven track record managing CROs and external vendors.
• Solid understanding of global regulatory requirements (ICH-GCP).
• Experience managing budgets and resource planning.
• Strong problem-solving skills with the ability to operate strategically and tactically.
• Excellent leadership, communication, and stakeholder management skills.
• Ability to thrive in a fast-paced, evolving biotech environment.
• Experience in rare/orphan diseases and/or academic collaborations is a plus.
• Education
• Bachelor’s degree in Life Sciences required.
• Advanced degree (MS, PhD, or equivalent) preferred.
• Substantial experience leading Clinical Operations and Data Management teams.
• Experience in rare disease; gene and cell therapy experience is a plus

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