Executive Director, API Development, Small Molecule Remote (anywhere in United States)

The Company is seeking an Executive Director for API Development in Small Molecules. This pivotal role is focused on leading the strategic direction of API development for the company's small molecule pipeline within technical operations. The successful candidate will be responsible for overseeing synthesis and process development activities for preclinical and clinical candidates, serving as a key advisor to executive leadership on development strategy, and influencing portfolio decisions. The role also involves driving cross-functional initiatives, fostering innovation, and ensuring a strong patient-focused culture. The ideal candidate will have a PhD with 10 years, an MS with 12 years, or a BS with 15 years of CMC experience in the pharmaceutical industry, with extensive expertise in route design, process development, technology transfer, and regulatory strategy for small molecule APIs. Applicants for the Executive Director position at the company should be prepared to manage multiple programs, resources, and staff, and have a proven track record of driving transformational change and continuous improvement. The role requires exceptional communication, negotiation, and influencing skills, as well as the ability to interact with executive leadership, regulatory agencies, and external partners. A strong commitment to experimental work, a thorough understanding of regulatory requirements, and experience with authoring and approving CMC sections of regulatory submissions are essential. The candidate should also have a background in working with CRO/CMOs and be adept at developing organizational talent. While not mandatory, experience with compounds used for inhalation and combination products is a plus. The position is fully remote, and the company values a culture that is human, curious, and dedicated to the meaningful progress of science.

Hiring Company

Insmed Incorporated