Senior Director, Nonclinical Development & Life‑Cycle

Organon; Philadelphia (Philadelphia County); On-site; USD 152,000 - 259,000; Full time

Job summary

Organon is seeking a Director of Nonclinical Development to provide subject-matter expertise across Women’s Health, General Medicines and Biosimilars, reporting to the Executive Director of Translational Sciences and Nonclinical Development.

The role leads ADTs, authoring nonclinical modules, briefing books, and regulatory submissions, coordinating with Regulatory, Safety, and CMC teams, and contributing to risk assessments and lifecycle management.

Qualifications

• PhD or DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.
• Board certification in toxicology a plus (e.g., DABT, ERT).
• 10+ years in pharmaceutical/biotech with nonclinical focus across toxicology, DMPK and pharmacology.

Responsibilities

• Serve as the Nonclinical representative on asset development teams for lifecycle management.
• Author/review nonclinical CTD modules, briefing books, and regulatory communications.
• Nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities.
• Provide toxicology input for Organon products and ADTs.

Skills

Nonclinical leadership

Regulatory submissions

Toxicology

DMPK

Communication

Project leadership

Education

PhD or DVM

Job description

Organon is seeking a Director of Nonclinical Development to provide subject-matter expertise across Women’s Health, General Medicines and Biosimilars, reporting to the Executive Director of Translational Sciences and Nonclinical Development.

The role leads ADTs, authoring nonclinical modules, briefing books, and regulatory submissions, coordinating with Regulatory, Safety, and CMC teams, and contributing to risk assessments and lifecycle management.