This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

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.

• 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.
• 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.

Qualifications

• 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.

Requirements

• This can be a fully remote role with occasional travel for team meetings or events.
• 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%).

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.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
• 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.