Executive Director, API Development, Small Molecule

About the role

As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, Insmed seeks an Executive Director, API Development, Small Molecule on the CMC Product Development team. Reporting to the Vice President of Product Development – CMC, Small Molecule, you will lead the strategic direction of API development for the company’s small molecule pipeline within Technical Operations, oversee synthesis and process development activities for preclinical and clinical candidates, and serve as a key advisor to executive leadership on development strategy, manufacturing technologies, and portfolio decisions while building organizational capabilities and developing future leaders.

Responsibilities

• Establish and execute the long‑term vision, strategy, and operating model for API Development, ensuring alignment with portfolio objectives and corporate strategy.
• Provide strategic leadership for API development, API process development, technology transfer, process validation, manufacturing readiness, and lifecycle management across development programs.
• Serve as a key member of the Technical Operations leadership teams, influencing portfolio decisions, resource allocation, risk mitigation strategies, and investment priorities.
• Direct the design and scale‑up of processes, instruments and equipment from the laboratory through pilot plant and manufacturing scale‑up.
• Manage the science and engineering underlying the development, implementation, and maintenance of process methods and equipment for the production of process formulas, technologies and products to achieve cost effectiveness and improved product quality.
• Plan and implement the development of new process formulas, establish operating equipment specifications, and improve manufacturing techniques and new process equipment production.
• Regularly interact with vendors, regulatory bodies and other external stakeholders, exerting influence and negotiating to drive business results.
• Represent the company externally through scientific publications, conference presentations, industry forums, advisory boards, and strategic collaborations.
• Develop organizational talent through coaching, succession planning, leadership development, and creation of a high‑performing and inclusive culture.
• Establish enterprise metrics and performance frameworks that ensure execution excellence, accountability, and continuous improvement across the Pharmaceutical Development function.

Requirements

• PhD with 10 years of CMC experience OR MS with 12 years of CMC experience OR BS with 15 years of CMC experience within the pharmaceutical industry.
• Extensive expertise in route design, process development, technology transfer, process validation, manufacturing sciences, regulatory strategy, and commercialization readiness for small molecule APIs.
• Strong commitment to experimental work and the ability to independently identify and solve complex problems to advance projects through the development process.
• Thorough understanding of cGxP, CMC, ICH and compendial (USP/EP/JP) regulatory requirements.
• Experienced with authoring, reviewing and approving CMC sections of regulatory submissions including INDs, NDAs/MAAs and other required documentation.
• Demonstrated track record of managing multiple programs, resources and staff from early discovery through commercialization.
• Extensive expertise in working with CRO/CMO's both as a lead and a team member.
• Track record of driving transformational change, organizational capability building, and continuous improvement initiatives.
• Exceptional communication, negotiation, and influencing skills, including interactions with executive leadership, regulatory agencies, external partners, and scientific organizations.

Skills

• Experience with compounds used for inhalation and combination products (nice to have).

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support.
• Annual wellbeing reimbursement and access to the 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, participation in the 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.

Pay

$247,000.00‑$337,000.00 Annual

Schedule

Fully remote role; occasional travel (approximately 25%) expected for team meetings or events.