Director, Nonclinical Development (part time)

About the role

The Director, Nonclinical Development is responsible for providing nonclinical subject matter expertise to support programs across Women’s Health, General Medicines, and Biosimilars. This position reports to the Executive Director, Translational Sciences and Nonclinical Development and collaborates with early and late clinical development, regulatory affairs, safety and pharmacovigilance, CMC, medical affairs, and business development as needed. The role serves as the nonclinical representative on asset development teams (ADTs) to support life-cycle management of products in the portfolio, contributes to and reviews nonclinical modules for regional and global regulatory submissions, authors and reviews briefing books, investigator brochures, and other regulatory documents, and supports toxicological risk assessments tied to CMC activities.

Responsibilities

• Serve as the Nonclinical representative on ADTs to develop and execute life-cycle management activities for products in the portfolio.
• Author and review nonclinical CTD modules, briefing books, or other regulatory communications for regional submissions or renewals and global products within the portfolio.
• Act as the nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities supporting the Women’s Health, General Medicines, and Biosimilars portfolio.
• Conduct nonclinical toxicology liaison with CMC and Occupational Safety to perform risk assessments and inform mitigation strategies per regional and/or global regulatory requirements.
• Collaborate with CMC to assess process manufacturing impurities, degradants, and extraneous matters and conduct risk assessments to inform mitigation strategies per regional and/or global regulatory requirements.
• Provide scientific and nonclinical input (toxicology, pharmacology, DMPK) for products and ADTs.
• Prepare, contribute to, and/or review nonclinical or CMC documentation to support regulatory submissions to 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 reviewing nonclinical literature for new risks, evaluating signals from pharmacovigilance or Health Authority communications, and authoring responses to regulatory inquiries.
• Contribute to regional or global product label reviews and updates as appropriate.
• Provide nonclinical support for occupational and environmental risk assessments.
• Support the established product portfolio in line with GLP, GCP, and relevant SOPs.

Education / Certificates

• Master's, 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).

Experience / Training

• 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 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 reviewing 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.

Skills

• Exemplifies leadership qualities including effective communication and collaboration, integrity, and respectful interactions.
• Excellent organizational and interpersonal skills.
• Ability to process and articulate complex ideas clearly to less technically trained audiences.
• Ability to prioritize and focus on critical data and considerations to drive results and provide solution-oriented recommendations with appropriate scientific rationale to address challenges in life-cycle management and CMC activities.

Target Pay Rate: $90–$100/hr; salary commensurate with experience.