Director, Nonclinical Development
Core
Provide nonclinical subject matter expertise and serve as the nonclinical representative on asset development teams to support life-cycle management of products in Organon's portfolio.
Role type
Director, Nonclinical Development (Senior Leadership)
Builds
Regulatory submissions (CTD modules, briefing books), risk assessments, and product labels for Women's Health, General Medicines, and Biosimilars.
Domain
Pharmaceutical/Biotech, Nonclinical Development, Toxicology, Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Nonclinical toxicology, DMPK, pharmacology, regulatory dossier authoring (NDAs), CMC impurity risk assessment, GLP/GxP compliance, agency interaction management
Preferred skills
Board certification in toxicology (DABT, ERT), global project team leadership
Technologies
None stated
Responsibilities
Serve as nonclinical representative on ADTs for life-cycle management; Author and review nonclinical CTD modules and regulatory communications; Act as nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance; Conduct toxicological risk assessments with CMC regarding manufacturing impurities and degradants; Provide scientific input (toxicology, pharmacology, DMPK) for products; Support regulatory submissions and interactions with Health Authorities; Support Drug Safety and Pharmacovigilance activities including literature review and signal evaluation; Contribute to product label reviews and updates.
Seniority
Director, Strategic Leadership & Cross-functional Collaboration
