Vice President, Product Development – CMC, Gene Therapy and Large Molecules

Role Summary

Vice President, Product Development – CMC, Gene Therapy and Large Molecules. Lead the gene therapy and large molecules pipeline from preclinical through clinical development and regulatory approvals, shaping strategy and building high-performing teams to advance innovative therapies.

Responsibilities

• Define and execute the product development strategy for all gene therapy and large molecule programs, providing strategic direction throughout the development lifecycle up to product approvals and launch.
• Oversee clinical development activities, coordinating with cross-functional leaders to ensure seamless execution of trials and achievement of regulatory milestones.
• Ensure Chemistry, Manufacturing, and Controls activities yield manufacturable, scalable, and compliant processes while maintaining supply chain readiness for clinical and commercial needs.
• Support global regulatory strategies by contributing to IND filings, BLA submissions, and pursuing orphan and rare disease designations that align with therapeutic focus areas.
• Build and mentor a high-performing product development team, fostering a culture of innovation and accountability and developing internal talent.
• Collaborate with external stakeholders including CDMOs and raw material suppliers to ensure reliable partnerships that support development timelines and quality standards.
• Lead cutting-edge gene therapy development and inspire a world-class team in the genetic medicine field.

Qualifications

• PhD or advanced degree in molecular biology, biotechnology, chemical engineering, or related field.
• 12‚Äì15+ years of progressive leadership experience in biopharma, with a strong track record in gene therapy or advanced biologics.
• Demonstrated success in advancing therapies through IND, clinical development, and regulatory approvals.
• Deep understanding of vector biology (AAV, etc.), CMC requirements, and manufacturing for gene therapy.
• Strong leadership, communication, and organizational skills with proven ability to influence at all levels.
• Strategic thinker with the ability to operate effectively in a dynamic, fast-paced environment.

Skills

• Leadership and people development
• Strategic planning and execution
• Cross-functional collaboration
• Regulatory strategy and submissions
• CMC and manufacturing for gene therapy
• Vector biology and gene therapy platforms

Education

• PhD or advanced degree in relevant field.

Additional Requirements

• Travel: Occasional global travel required (approximately 30%). Remote-friendly with option for location near Bridgewater, NJ.