Director, Nonclinical Development

Role: The Director of Nonclinical Development provides scientific expertise in toxicology, pharmacology, and DMPK to support Organon's product portfolio in Women’s Health, General Medicines, and Biosimilars. Responsibilities include leading nonclinical contributions to regulatory submissions, reviewing nonclinical modules and safety documentation, and serving as the nonclinical liaison in asset development teams for lifecycle management. The role also involves risk assessments for CMC activities and collaboration with regulatory, safety, and manufacturing functions. Requirements: PhD, DVM, or equivalent in a relevant science, with at least 10 years’ industry experience across nonclinical disciplines, including late-stage drug development and regulatory dossier preparation. Board certification in toxicology (e.g., DABT) is a plus. High-Value: Emphasis on supporting global regulatory submissions, GxP compliance, and collaborating across cross-functional teams. Therapeutic areas include Women’s Health, Biosimilars, and General Medicines, with responsibilities spanning toxicology, risk assessment, and regulatory interactions. Work setup involves global responsibilities with no specific location stated; travel requirements are not specified.