The Company is seeking an Executive Director for Pharmaceutical Development, Small Molecule. This pivotal role involves leading the strategic direction of the pharmaceutical development function for the company's small molecule pipeline. The successful candidate will be responsible for overseeing formulation, drug product development, manufacturing readiness, and CMC innovation across the portfolio. Key responsibilities include ensuring the efficient progression of assets from early development to commercialization, aligning with corporate goals, regulatory requirements, and industry trends, and serving as a key advisor to executive leadership on development strategy and portfolio decisions. The role also demands a strong commitment to experimental work, the ability to solve complex problems, and a track record of driving transformational change and continuous improvement. Applicants for this role at the company should have a PhD with 10 years, an MS with 12 years, or a BS with 15 years of CMC experience in the pharmaceutical industry. Extensive expertise in formulation development, process development, technology transfer, process validation, manufacturing sciences, and regulatory strategy is essential. The ideal candidate will have a thorough understanding of cGxP, CMC, ICH, and compendial regulatory requirements, and a proven track record of managing multiple programs from discovery to commercialization. Strong leadership, communication, and influencing skills are required, as is the ability to build and maintain strategic relationships with various stakeholders. Experience with alternate dosage forms and a background in inhalation and combination products is a plus.

Hiring Company

Insmed Incorporated