Director, Nonclinical Development

About the role

The Director, Nonclinical Development provides nonclinical subject matter expertise to support programs in Organon’s portfolio of products across Women’s Health, General Medicines, and Biosimilars. This position reports to the Executive Director, Translational Sciences and Nonclinical Development and collaborates with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, chemistry, manufacturing and control (CMC), medical affairs, and business development. The role serves as the nonclinical representative on asset development teams (ADTs) to support life-cycle management of products and contributes to nonclinical modules for regional regulatory submissions and renewals for global submissions.

Responsibilities

• Serve as the Nonclinical representative on ADTs in the development and execution of life-cycle management activities for products in Organon’s portfolio.
• Author and review nonclinical CTD modules, briefing books, or other regulatory communications for regional regulatory submissions or renewals for global products.
• Act as the nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities supporting the Organon Women’s Health, General Medicines, and Biosimilars product portfolio.
• Serve as the nonclinical toxicology liaison with CMC and Occupational Safety to conduct risk assessments and inform mitigation strategies in accordance with regional and/or global regulatory requirements.
• Collaborate with CMC to assess process manufacturing impurities, degradants, and/or extraneous matters and conduct risk assessments to inform mitigation strategies.
• Provide scientific and nonclinical input (toxicology, pharmacology, DMPK) for Organon products and ADTs.
• Prepare, contribute to, and/or review nonclinical or CMC documentation to support regulatory submissions to regional Health Authorities worldwide; may participate in interactions with Health Authorities.
• Support Regulatory activities for global products, including annual reporting of nonclinical activities and literature, new regional drug applications, regional license renewals, and authoring responses to questions from global Health Authorities.
• Support Drug Safety and Pharmacovigilance with activities such as review of nonclinical literature for new risks, signal evaluation, and authoring responses to regulatory inquiries.
• Contribute to regional or global product label reviews and updates.
• Collaborate with CMC and Occupational Safety to evaluate process manufacturing impurities and/or degradants and conduct risk assessments.
• Provide nonclinical support for occupational and environmental risk assessments.
• Support the established product portfolio in line with Good Laboratory Practices (GLP), Good Clinical Practice (GCP), and relevant Organon Standard Operating Procedures (SOPs).

Requirements

• 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 the context of drug development, including toxicology, DMPK, and pharmacology.
• Demonstrated technical and scientific knowledge in nonclinical sciences with a particular emphasis on supporting late-stage drug development and life-cycle management.
• Demonstrated knowledge of nonclinical development as well as drug substance and drug product impurity-related regulatory guidelines and GxP requirements.
• Extensive experience with review and authoring nonclinical sections of regulatory dossiers (e.g., NDAs) and product labels with first-hand experience in agency interactions (meetings, briefing books, and response documents).
• Experience working in project teams (preferably global project teams).
• Exemplifies leadership qualities including effective communication and collaboration, integrity, and respectful interactions with Organon personnel.
• Excellent organizational and interpersonal skills.
• Ability to process and articulate complex ideas clearly to less technically trained individuals.
• Ability to prioritize and focus on important data and considerations to drive results and provide solution-oriented recommendations with an appropriate scientific rationale.

Pay

Annualized salary range for this position in the U.S. is $152,300.00 - $259,200.00. Pay ranges are specific to local market and vary from country to country.

Benefits

• Retirement savings plan.
• Paid vacation and holiday time.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.