Director, Nonclinical Development - Remote Part-Time

Spectraforce Technologies; Raleigh (NC); On-site; USD 90,000 - 120,000; Part time

Job summary

The Director, Nonclinical Development at Organon is responsible for providing nonclinical expertise to support programs across Women's Health, General Medicines, and Biosimilars. This role reports to the Executive Director, Translational Sciences and Nonclinical Development and collaborates with Regulatory Affairs, Safety and Pharmacovigilance, and CMC to ensure lifecycle management and regulatory submissions.

Remote, part-time (20 hours/week) for 12 months.

Qualifications

• Minimum 10 years in pharmaceutical/biotech with non-clinical disciplines.
• Extensive experience authoring nonclinical sections of regulatory dossiers.
• Experience with agency interactions and global teams.

Responsibilities

• Serve as the Nonclinical representative on asset teams for lifecycle management.
• Author/review nonclinical CTD modules and regulatory documents for submissions.
• Provide nonclinical input for regulatory, safety and pharmacovigilance activities.
• Collaborate with CMC and Safety to assess process-related risks and mitigations.
• Support GLP and GCP compliance across activities and documents.
• Coordinate regional/global regulatory interactions and submissions.

Skills

Leadership

Communication

Organization

Analytical thinking

Scientific knowledge

Education

Master's, PhD, DVM or equivalent in pharmacology/biology/physiology/biochemistry/chemistry/toxicology

Toxicology board certification (DABT/ERT) a plus

Job description

The Director, Nonclinical Development at Organon is responsible for providing nonclinical expertise to support programs across Women's Health, General Medicines, and Biosimilars. This role reports to the Executive Director, Translational Sciences and Nonclinical Development and collaborates with Regulatory Affairs, Safety and Pharmacovigilance, and CMC to ensure lifecycle management and regulatory submissions.

Remote, part-time (20 hours/week) for 12 months.