Director, Nonclinical Development — Lifecycle Leader

Femtech Insider Ltd.; United States; On-site; USD 152,000 - 259,000; Full time

Job summary

Organon seeks a Director of Nonclinical Development to provide senior scientific leadership across Women’s Health, General Medicines and Biosimilars. The role collaborates with early and late clinical development, regulatory affairs, safety, CMC, and medical affairs to advance lifecycle management.

The candidate will author and review nonclinical modules for regulatory submissions, contribute to risk assessments, and support global health authority interactions.

Qualifications

• PhD or equivalent with focused expertise in nonclinical sciences (toxicity, DMPK, pharmacology).
• 10+ years in pharma/biotech with extensive nonclinical knowledge across drug development.
• Experience writing nonclinical sections of regulatory dossiers (NDAs) and product labels; interactions with agencies.

Responsibilities

• Serve as the Nonclinical representative on asset development teams for lifecycle management.
• Author/review nonclinical CTD modules, briefing books, and regulatory communications for global submissions.
• Act as nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities across Women’s Health, General Medicines and Biosimilars.
• Provide input on toxicology, pharmacology, and DMPK for Organon products and ADTs.
• Prepare/regulatory submissions support documents; participate in Health Authority interactions as needed.
• Support GLP/GCP compliance and Organon SOPs in line with regulatory expectations.

Skills

Nonclinical development

Toxicology

DMPK

Pharmacology

Regulatory knowledge

Education

PhD, DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences

Job description

Organon seeks a Director of Nonclinical Development to provide senior scientific leadership across Women’s Health, General Medicines and Biosimilars. The role collaborates with early and late clinical development, regulatory affairs, safety, CMC, and medical affairs to advance lifecycle management.

The candidate will author and review nonclinical modules for regulatory submissions, contribute to risk assessments, and support global health authority interactions.