Director, Nonclinical Development & Lifecycle Strategy

Biopharma Careers; Florham Park (NJ); On-site; USD 152,000 - 259,000; Full time

Job summary

Organon in the United States is seeking a Director, Nonclinical Development to provide subject matter expertise across Women’s Health, General Medicines and Biosimilars, guiding late-stage development and lifecycle management.

You will author nonclinical modules, support regulatory submissions, collaborate with cross-functional partners, and advise on toxicology and DMPK risk assessments to ensure global compliance.

Qualifications

• PhD, DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.
• Board certification in toxicology a plus (e.g., DABT, ERT).
• A minimum of 10 years of experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge across nonclinical disciplines in drug development (toxicology, DMPK, pharmacology).
• Experience reviewing nonclinical sections of regulatory dossiers (e.g., NDAs) and product labels, with familiarity with agency interactions.

Responsibilities

• Serve as the Nonclinical representative on asset development teams for lifecycle management.
• Author and review nonclinical modules for regulatory submissions and renewals.
• Act as nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities.
• Contribute to/regulatory risk assessments for CMC and manufacturing.
• Provide input on toxicology, pharmacology, and DMPK for Organon products.
• Support global/regional regulatory submissions and health authority interactions.

Skills

Leadership

Communication

Collaboration

Integrity

Education

PhD, 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 of pharma/biotech nonclinical experience

Job description

Organon in the United States is seeking a Director, Nonclinical Development to provide subject matter expertise across Women’s Health, General Medicines and Biosimilars, guiding late-stage development and lifecycle management.

You will author nonclinical modules, support regulatory submissions, collaborate with cross-functional partners, and advise on toxicology and DMPK risk assessments to ensure global compliance.