Executive Director, Pharmaceutical Development, Small Molecule

About the role

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? We’re looking for an Executive Director, Pharmaceutical Development, Small Molecule on the CMC Product Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Vice President of Product Development – CMC, Small Molecule, you’ll lead the strategic direction of the Pharmaceutical Development function for the company’s small molecule pipeline within Technical Operations, overseeing formulation, drug product development, manufacturing readiness, and CMC innovation across the portfolio. You will ensure efficient progression of assets from early development through commercialization while aligning with corporate goals, regulatory requirements, and industry trends. You will serve as a key advisor to executive leadership on development strategy, manufacturing technologies, and portfolio decisions.

Responsibilities

• Provide strategic leadership by defining and executing the CMC strategy, and operating model for Pharmaceutical Development, small molecule, ensuring alignment with portfolio objectives and corporate strategy
• Provide strategic leadership for formulation development, drug product process development, technology transfer, process validation, manufacturing readiness, and lifecycle management across development programs
• Support global CMC regulatory strategies that align with our clinical and commercial objectives
• Drive innovation through evaluation and implementation of emerging formulation technologies, advanced manufacturing approaches, digital tools, and external scientific partnerships
• Lead organization-wide initiatives to enhance Pharmaceutical Development capabilities, operational excellence, scalability, and regulatory readiness
• Provide executive oversight for development and commercialization strategies for oral, parenteral, combination product, and other advanced small molecule dosage form programs
• Build and maintain strategic relationships with CDMOs, technology partners, regulatory agencies, academic institutions, and industry experts. 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

You have a PhD along with 10 years of CMC experience or MS and 12 years of CMC experience or BS and 15 years of CMC experience within the pharmaceutical industry.

Qualifications

• Extensive expertise in formulation development, process development, technology transfer, process validation, manufacturing sciences, regulatory strategy, and commercialization readiness for solid oral and liquid dosage forms
• A strong commitment to experimental work, as well as the ability to independently identify and solve complex problems to advance projects through the development process
• Experienced with alternate dosage forms, which include pediatric, geriatric and modified release
• 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
• Recognized internally and externally as a leader in pharmaceutical development, formulation sciences, and drug product development
• Track record of driving transformational change, organizational capability building, and continuous improvement initiative
• Exceptional communication, negotiation, and influencing skills, including interactions with executive leadership, regulatory agencies, external partners, and scientific organizations

Skills

Nice to have (but not required): Experience with inhalation and combination products.

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,