What are the responsibilities and job description for the Vice President Clinical Operations position at ClinLab Solutions Group?
About the Company
ClinLab Solutions Group has been engaged to identify a Vice President of Clinical Operations for a clinical-stage gene therapy company headquartered in New York City. This is a permanent leadership opportunity for a seasoned clinical operations executive ready to take full ownership of a pivotal program.
Our client is quickly advancing gene therapy programs, so this is not a role for someone looking to manage from a distance. The VP of Clinical Operations will set the operational vision, lead the team, govern CRO partners, and ensure every decision is made with the BLA submission and inspection environment fully in view.
About the Role
Full clinical operations leadership for a global gene therapy study from feasibility through regulatory submission and close-out.
Responsibilities
- Registration strategy alignment, ensuring operational execution supports the accelerated approval pathway from day one
- Site feasibility, investigator engagement, and site selection strategy across global regions
- CRO governance and performance oversight, with accountability for monitoring and site management vendor performance
- Inspection readiness planning and execution in anticipation of BLA submission requirements
- Vendor management across global regions including EU and South America; China experience a plus
- Development and ownership of clinical operations SOPs, systems, and processes as the program scales
- Cross-functional partnership with Clinical Development, Medical Affairs, Regulatory, and the executive team
- Representation of Clinical Operations at the leadership and governance level, including board and investor-facing contexts as needed
Qualifications
- 15 or more years of progressive Clinical Operations experience in biotech or pharma, with at least 3 years in a VP or equivalent senior leadership role
- Deep gene therapy or advanced biologics experience
- Demonstrated experience leading or supporting BLA and/or NDA submissions, with hands-on understanding of inspection readiness and submission-ready documentation
- Proven track record leading complex, global Phase 3 trials across multiple geographies
- Experience working across both large pharma infrastructure and the pace and accountability of a mid-size or clinical-stage biotech
- Strong CRO governance and vendor oversight capabilities across international regions
- A builder who can create structure and process without sacrificing execution speed
- A long-tenured leader with a record of program ownership and organizational impact
- Comfort with AI-enabled tools, decentralized trial models, or operational modernization is a plus
Location and Travel
- Must be based in the New York City metro area (Tri-State region)
- On-site at client's NYC office a minimum of 3 days per week
- Ability to attend in-person meetings on short notice
Salary : $300,000 - $350,000