Vice President, Clinical Operations

Job Title: Vice President, Clinical Operations

Work Location: New York County, New York

Summary:

Seeking an experienced executive to lead clinical operations for advanced gene therapy programs. This high-visibility leadership role requires hands-on oversight of global clinical studies, operational strategy, and cross-functional collaboration to drive successful regulatory submissions and program milestones.

Responsibilities:

• Lead all aspects of global clinical operations for gene therapy studies from feasibility through regulatory submission and study close-out.
• Align operational execution with registration strategy to support accelerated approval pathways.
• Develop and implement site feasibility, investigator engagement, and site selection strategies across multiple regions.
• Oversee CRO governance and performance, ensuring effective monitoring and site management vendor oversight.
• Plan and execute inspection readiness activities in preparation for regulatory submissions.
• Manage vendor relationships across global regions, including Europe and South America; experience with China is advantageous.
• Establish and maintain clinical operations SOPs, systems, and scalable processes as programs expand.
• Collaborate cross-functionally with clinical development, medical affairs, regulatory, and executive leadership, representing clinical operations at governance and board levels as needed.

Qualifications:

• 15+ years of progressive clinical operations experience in biotech or pharmaceutical settings, including at least 3 years in a senior leadership or VP role.
• Extensive experience in gene therapy or advanced biologics.
• Demonstrated leadership in BLA and/or NDA submissions, with expertise in inspection readiness and submission documentation.
• Proven ability to lead complex, global Phase 3 trials across diverse geographies.
• Background in both large pharma environments and mid-size or clinical-stage biotech organizations.
• Strong skills in CRO governance and international vendor oversight.
• Track record of building operational structure and process while maintaining execution speed.
• Long-term leadership experience with significant program ownership and organizational impact.
• Familiarity with AI-enabled tools, decentralized trial models, or operational modernization is a plus.
• Ability to work on-site in New York County, New York at least 3 days per week and attend in-person meetings on short notice.

Published Category: Clinical Operations & Development