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

Vice President, Product Development Cmc, Gene Therapy And Large Molecules

We are seeking a highly experienced and visionary Vice President, Product Development CMC, Gene Therapy and Large Molecules, to help us expand what's possible for patients with serious diseases. Reporting to the SVP, Technical Operations, you will lead our gene therapy and large molecules pipeline from preclinical through clinical development and regulatory approvals. In this role you will be a key member of the Technical Operations leadership team and play a critical role in shaping strategy, building high-performing teams, and advancing innovative therapies to patients.

As the Vice President, Product Development CMC, Gene Therapy and Large Molecules, you will define and execute the product development strategy for all gene therapy and large molecule programs, providing strategic direction and oversight throughout the development lifecycle and up through product approvals and launch.

In addition, you will oversee clinical development activities by working collaboratively with cross-functional leaders to ensure seamless execution of clinical trials and achieve regulatory milestones. Your role will be critical in coordinating efforts across multiple departments to advance our gene therapy and large molecule pipelines.

In this role you will also ensure that all Chemistry, Manufacturing, and Controls activities result in manufacturable, scalable, and compliant processes while maintaining supply chain readiness for both clinical and commercial needs. You will support global regulatory strategies by contributing to IND filings, BLA submissions, and pursuing orphan and rare disease designations that align with our therapeutic focus areas.

A key aspect of your role involves building and mentoring a high-performing product development team where you will foster a culture of innovation and accountability while developing talent within the organization.

Additionally, you will collaborate with external stakeholders including Contract Development and Manufacturing Organizations (CDMOs) and raw material suppliers to ensure reliable partnerships that support our development timelines and quality standards.

This position offers the opportunity to lead cutting-edge gene therapy development while building and inspiring a world-class team in the rapidly evolving field of genetic medicine.

Qualifications include :

• PhD, or advanced degree in molecular biology, biotechnology, chemical engineering, or related field.
• 1215+ 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.

This can be a fully remote role because the selected candidate should be able to perform effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Alternatively, if you live within a drivable distance of Bridgewater, NJ, you'll have the option to work remotely most of the time, but with more in-person collaboration when it matters most.

This role requires occasional global travel (approximately 30%).

Pay Range : $329,000.00-398,326.00 Annual