Director, Nonclinical Development
Organon
August 13, 2026
Remote friendly (Florham Park, NJ)
United States
Clinical Research and Development
Responsibilities:
- Serve as Nonclinical representative on Asset Development Teams (ADTs) for development and execution of life-cycle management activities.
- Author and review nonclinical CTD modules, briefing books, and other regulatory communications for regional submissions/renewals and global products.
- Act as nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities for Women’s Health, General Medicines, and Biosimilars.
- Serve as nonclinical toxicology liaison with CMC and Occupational Safety to conduct risk assessments and define mitigation strategies; assess impurities/degradants/extraneous matters.
- Provide scientific and nonclinical input (toxicology, pharmacology, DMPK) for products and ADTs.
- Prepare/contribute/review nonclinical or CMC documentation to support regulatory submissions worldwide; may participate in Health Authority interactions.
- Support global regulatory activities (annual reporting, new regional drug applications, license renewals, and responses to global Health Authority questions).
- Support Drug Safety/Pharmacovigilance (review nonclinical literature for new risks, signal evaluation, and regulatory inquiry responses).
- Contribute to regional/global label reviews and updates.
- Support occupational/environmental risk assessments.
- Support portfolio in accordance 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 (plus; e.g., DABT, ERT).
- 10+ years pharmaceutical/biotech experience with deep nonclinical drug development knowledge (toxicology, DMPK, pharmacology).
- Strong knowledge of nonclinical development and impurity-related regulatory guidelines and GxP.
- Extensive experience authoring/reviewing nonclinical regulatory dossier sections (e.g., NDAs) and product labels with agency interaction experience.
- Experience working in project teams (preferably global).
- Leadership, communication/collaboration, integrity; excellent organizational and interpersonal skills.
- Ability to articulate complex ideas to non-technical audiences and prioritize data to drive solution-oriented recommendations.
Application instructions: None provided.
- Serve as Nonclinical representative on Asset Development Teams (ADTs) for development and execution of life-cycle management activities.
- Author and review nonclinical CTD modules, briefing books, and other regulatory communications for regional submissions/renewals and global products.
- Act as nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities for Women’s Health, General Medicines, and Biosimilars.
- Serve as nonclinical toxicology liaison with CMC and Occupational Safety to conduct risk assessments and define mitigation strategies; assess impurities/degradants/extraneous matters.
- Provide scientific and nonclinical input (toxicology, pharmacology, DMPK) for products and ADTs.
- Prepare/contribute/review nonclinical or CMC documentation to support regulatory submissions worldwide; may participate in Health Authority interactions.
- Support global regulatory activities (annual reporting, new regional drug applications, license renewals, and responses to global Health Authority questions).
- Support Drug Safety/Pharmacovigilance (review nonclinical literature for new risks, signal evaluation, and regulatory inquiry responses).
- Contribute to regional/global label reviews and updates.
- Support occupational/environmental risk assessments.
- Support portfolio in accordance 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 (plus; e.g., DABT, ERT).
- 10+ years pharmaceutical/biotech experience with deep nonclinical drug development knowledge (toxicology, DMPK, pharmacology).
- Strong knowledge of nonclinical development and impurity-related regulatory guidelines and GxP.
- Extensive experience authoring/reviewing nonclinical regulatory dossier sections (e.g., NDAs) and product labels with agency interaction experience.
- Experience working in project teams (preferably global).
- Leadership, communication/collaboration, integrity; excellent organizational and interpersonal skills.
- Ability to articulate complex ideas to non-technical audiences and prioritize data to drive solution-oriented recommendations.
Application instructions: None provided.