Director, Nonclinical Development

Role: Senior nonclinical expert providing pharmacology, toxicology, and DMPK support for drug development and lifecycle management within Organon's Women’s Health, General Medicines, and Biosimilars portfolios. Responsibilities: serve as nonclinical representative on asset development teams; author/review nonclinical modules for regulatory submissions; support toxicological risk assessments, CMC activities, and safety evaluations; collaborate with cross-functional teams including regulatory affairs, safety, and CMC; prepare documentation for global health authority interactions and product labeling updates; support post-approval activities such as renewals and literature reviews. Requirements: PhD, DVM, or equivalent in pharmacology, biology, or related field; 10+ years' industry experience with extensive knowledge of nonclinical sciences, GxP, and drug development; proven experience in regulatory dossier review and agency interactions; strong leadership, communication, and collaboration skills. HighValue: support of late-stage drug development, lifecycle management, global regulatory submissions, nonclinical module authoring, toxicology and DMPK expertise, biosimilars, women’s health products. WorkSetup: not specified; travel requirements not detailed.