Senior Director, CMC Leadership & Diligence, Early Asset Leadership and Evaluation

Role: Senior Director, CMC Diligence & Leadership within Early Asset Evaluation & Development, responsible for shaping in-licensing, alliance, and M&A strategies for biologics, small molecules, and novel modalities. Objectives include leading technical due diligence, evaluating drug substance, drug product, regulatory readiness, and manufacturing risks, and integrating assets post-transaction. Core responsibilities encompass developing CMC diligence strategies, leading cross-functional teams, negotiating deal terms, assessing costs and risks, and presenting findings to senior leadership. The role also involves developing and executing integrated CMC development strategies across phases from candidate nomination to market, influencing regulatory strategies, and championing operational excellence. The position requires extensive interaction with Business Development, Legal, Finance, and other R&D functions, and presentation to governance bodies. Qualifications include a PhD or advanced degree in chemistry, biochemical/chemical engineering, with 15+ years in biopharma, including business development, deal diligence, and cross-functional leadership. Expertise in biologics drug development, manufacturing, and supply chain across development stages is essential. Proven ability to analyze complex technical data, support negotiations, and communicate strategically to executive audiences is mandatory. Experience with global regulatory guidelines (FDA, EMA, ICH) and managing CMC teams across modalities is preferred. The work location is in New Brunswick or Princeton, NJ, with up to 10% travel. The role demands high-level scientific judgment, strategic thinking, and leadership in a senior cross-functional environment.