Director, Nonclinical Development: Life-Cycle & Regulatory Lead

Organon; Pennsylvania; On-site; USD 152,000 - 259,000; Full time

Job summary

Organon seeks a Director of Nonclinical Development to provide subject-matter expertise across Women’s Health, General Medicines, and Biosimilars. Reporting to the Executive Director, Translational Sciences and Nonclinical Development, the role collaborates with clinical, regulatory, safety, CMC, and other teams to support life-cycle management and global submissions.

The candidate will author and review nonclinical modules, briefing books, and regulatory documents, contributing to toxicology

Qualifications

• PhD, DVM or equivalent in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.
• Board certification in toxicology a plus (e.g., DABT, ERT).
• At least 10 years in pharma/biotech with nonclinical depth.
• Strong knowledge across nonclinical disciplines in context of drug development.
• Experience with regulatory dossiers (NDAs) and agency interactions.
• Experience in global project teams and cross-functional collaboration.
• Excellent communication, organization, and leadership.

Responsibilities

• Serve as the nonclinical representative on ADTs for lifecycle management.
• Author and review nonclinical CTD modules and regulatory documents.
• Act as nonclinical contact for Regulatory, Safety, Pharmacovigilance.
• Collaborate with CMC on risk assessments and impurities.
• Provide nonclinical input for Organon products and ADTs.
• Prepare nonclinical/CMC documentation for regulatory submissions.
• Support regulatory activities for global products and annual reporting.
• Support Drug Safety with literature reviews and responses to inquiries.
• Contribute to product label reviews and updates.
• Coordinate GLP/GCP-compliant work in line with SOPs.

Skills

Nonclinical expertise

Toxicology knowledge

Regulatory experience

Leadership and collaboration

Communication skills

Education

PhD or DVM in related sciences

Toxicology board certification (a plus)

Job description

Organon seeks a Director of Nonclinical Development to provide subject-matter expertise across Women’s Health, General Medicines, and Biosimilars. Reporting to the Executive Director, Translational Sciences and Nonclinical Development, the role collaborates with clinical, regulatory, safety, CMC, and other teams to support life-cycle management and global submissions.

The candidate will author and review nonclinical modules, briefing books, and regulatory documents, contributing to toxicology