Job Title: Sr. Director, Clinical Operations (Consultant)

Work Location: New York County, New York

Summary:

This is a 6-month, full-time consulting opportunity for a Senior Director, Clinical Operations to lead the operational execution of a pivotal, late-stage gene therapy clinical trial. The role requires deep expertise in clinical operations, particularly in gene therapy or complex biologics, and a strong understanding of regulatory submission processes. The position involves significant cross-functional leadership, vendor oversight, and a focus on inspection readiness and operational excellence.

Responsibilities:

• Lead operational execution of a global, late-stage gene therapy clinical trial, ensuring alignment with registrational objectives.
• Oversee trial activities from feasibility through close-out, maintaining focus on inspection readiness and regulatory requirements.
• Develop and implement feasibility strategies, site selection, and engagement with key investigators.
• Provide governance and oversight of contract research organization partners responsible for monitoring and site management.
• Manage vendor relationships and performance across multiple global regions, including Europe and South America, with China as a plus.
• Contribute to the development and refinement of clinical operations processes and standard operating procedures.
• Collaborate cross-functionally with clinical development, medical, and executive leadership teams to support accelerated approval planning.
• Attend in-person meetings in the local area on short notice and travel as required (20-25%).

Qualifications:

• 15+ years of progressive experience in clinical operations within the biotech or pharmaceutical industry.
• Senior Director-level experience preferred.
• Extensive background in gene therapy or advanced biologics.
• Experience supporting BLA and/or NDA submissions, with a strong understanding of submission processes and inspection readiness.
• Proven leadership in managing complex, global, late-stage clinical trials.
• Demonstrated ability to work in both large pharmaceutical and mid-sized biotech environments.
• Deep experience in CRO governance and vendor oversight.
• Proactive, high-energy leadership style with a track record of program ownership and tenure.
• Strategic and tactical operator, skilled at building and executing clinical trial processes.
• Innovative mindset, with experience modernizing clinical operations, leveraging AI tools, or implementing decentralized trial models considered a plus.
• Must be located in the Tri-State area and willing to travel 20-25%.
• Comfortable attending in-person meetings on short notice.
• Strong professional references required.

Published Category: Clinical Operations & Development