Director, Nonclinical Development
Organon
August 13, 2026
Remote friendly (Greater Philadelphia)
United States
Clinical Research and Development
Responsibilities:
- Serve as the Nonclinical representative on Asset Development Teams (ADTs) for life-cycle management.
- Author and review nonclinical CTD modules, briefing books, and other regulatory communications for regional submissions/renewals.
- Act as nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance for Women’s Health, General Medicines, and Biosimilars.
- Conduct nonclinical toxicology risk assessments with CMC and Occupational Safety; assess process impurities/degradants/extraneous matters and recommend mitigation strategies per regulatory requirements.
- Provide scientific/nonclinical input (toxicology, pharmacology, DMPK) for products and ADTs.
- Prepare/contribute/review nonclinical or CMC documentation for regulatory submissions to global Health Authorities; may participate in agency interactions.
- Support regulatory activities for global products (annual reporting, new applications, license renewals, and responses to global Health Authorities).
- Support Drug Safety/Pharmacovigilance via review of nonclinical literature for new risks, signal evaluation, and responses to inquiries.
- Contribute to regional/global product label reviews and updates.
- Support portfolio in alignment with GLP, GCP, and relevant SOPs.
Required Education/Experience/Skills:
- PhD/DVM or equivalent in pharmacology, biology, physiology, biochemistry, chemistry, toxicology, or related sciences.
- Board certification in toxicology is a plus (e.g., DABT, ERT).
- 10+ years in pharma/biotech with deep nonclinical drug development knowledge (toxicology, DMPK, pharmacology).
- Strong knowledge of nonclinical development, drug substance/product impurity regulatory guidelines, and GxP.
- Extensive experience authoring/reviewing nonclinical sections of regulatory dossiers and product labels with agency interaction experience.
- Experience in project teams (preferably global).
- Leadership, communication, collaboration, organizational/interpersonal skills; ability to explain complex ideas to non-technical stakeholders and prioritize data to provide solution-oriented recommendations.
- Serve as the Nonclinical representative on Asset Development Teams (ADTs) for life-cycle management.
- Author and review nonclinical CTD modules, briefing books, and other regulatory communications for regional submissions/renewals.
- Act as nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance for Women’s Health, General Medicines, and Biosimilars.
- Conduct nonclinical toxicology risk assessments with CMC and Occupational Safety; assess process impurities/degradants/extraneous matters and recommend mitigation strategies per regulatory requirements.
- Provide scientific/nonclinical input (toxicology, pharmacology, DMPK) for products and ADTs.
- Prepare/contribute/review nonclinical or CMC documentation for regulatory submissions to global Health Authorities; may participate in agency interactions.
- Support regulatory activities for global products (annual reporting, new applications, license renewals, and responses to global Health Authorities).
- Support Drug Safety/Pharmacovigilance via review of nonclinical literature for new risks, signal evaluation, and responses to inquiries.
- Contribute to regional/global product label reviews and updates.
- Support portfolio in alignment with GLP, GCP, and relevant SOPs.
Required Education/Experience/Skills:
- PhD/DVM or equivalent in pharmacology, biology, physiology, biochemistry, chemistry, toxicology, or related sciences.
- Board certification in toxicology is a plus (e.g., DABT, ERT).
- 10+ years in pharma/biotech with deep nonclinical drug development knowledge (toxicology, DMPK, pharmacology).
- Strong knowledge of nonclinical development, drug substance/product impurity regulatory guidelines, and GxP.
- Extensive experience authoring/reviewing nonclinical sections of regulatory dossiers and product labels with agency interaction experience.
- Experience in project teams (preferably global).
- Leadership, communication, collaboration, organizational/interpersonal skills; ability to explain complex ideas to non-technical stakeholders and prioritize data to provide solution-oriented recommendations.