Vice President, Product Development - CMC, Small Molecules

Insmed Incorporated

18d • $290,000 - $396,000 • Remote

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We are seeking a highly experienced and visionary Vice President, Product Development – CMC, Small Molecules, to help us expand what’s possible for patients with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (CMC) activities for the company’s small molecule pipeline. As a senior leader, you will oversee drug substance and drug product development, analytical development, and combination product development. To be successful in this position, you will be a strategic leader, ensuring that development programs meet scientific, quality, regulatory, and commercial standards, while ensuring execution across internal teams and external partners (CDMO, CMOs).

Requirements

• Ph.D. or advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.
• 15+ years of progressive experience in CMC development for small molecule pharmaceuticals, with at least 7 years in senior leadership.
• Proven track record in advancing programs from preclinical to commercial launch.
• Deep knowledge of small molecule process chemistry, formulation, and analytical development.
• Demonstrated success in regulatory submissions and global CMC regulatory requirements.
• Experience managing external partners (CMOs/CDMOs).
• Strong leadership, strategic thinking, and communication skills.

Responsibilities

• Provide strategic leadership by defining and executing the CMC strategy for all small molecule programs throughout their lifecycle, from preclinical development through commercialization.
• Serve as a key member of the Technical Operations leadership team and contribute significantly to our overall product development strategy.
• Lead both drug substance (API) and drug product development initiatives, including formulation development, process chemistry, and scale-up operations.
• Oversee analytical method development and validations and have experience in combination devices.
• Ensure manufacturing readiness for both clinical and commercial supply chains.
• Support global CMC regulatory strategies that align with our clinical and commercial objectives.
• Author, review, and approve CMC sections of regulatory submissions including INDs, NDAs/MAAs, and other required documentation.
• Ensure compliance with ICH, FDA, EMA, PMDA and other international regulatory guidelines.
• Build and lead a high-performing CMC team while managing relationships with external manufacturing partners and CDMOs to ensure reliable clinical supply and maintain quality standards.
• Partner with Discovery, Clinical Development, Quality, Regulatory Affairs, Operations, and Commercial teams to ensure seamless program advancement.
• Provide technical expertise and due diligence support for business development opportunities.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree