Director, Nonclinical Development

About the role

The Director, Nonclinical Development is responsible for providing nonclinical subject matter expertise to support programs in a 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 and late clinical development, regulatory affairs, safety and pharmacovigilance, chemistry, manufacturing and control (CMC), medical affairs, and business development as necessary. The role serves as the nonclinical representative on asset development teams (ADTs) to support life-cycle management of products in the portfolio and contributes to regional regulatory submissions and renewals for global submissions. The position also author and review briefing books, investigator brochures, and other regulatory documents, and supports toxicological risk assessments associated with CMC activities.

Responsibilities

• Serve as the Nonclinical representative on ADTs in the development and execution of life-cycle management activities for products in portfolio.
• Author and review nonclinical CTD modules, briefing books, or other regulatory communications for regional regulatory submissions or renewals for 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 product portfolio.
• Serve as the nonclinical toxicology liaison with CMC and Occupational Safety to conduct risk assessments to 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 in accordance with 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 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, support for new regional drug applications, regional license renewals, and author 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 for issues identified through pharmacovigilance or communications through Health Authorities, and author responses to regulatory inquiries as appropriate.
• 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 Good Laboratory Practices (GLP), Good Clinical Practice (GCP), and relevant Standard Operating Procedures (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 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 with 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 with personnel.
• Excellent organizational and interpersonal skills.
• Ability to process and articulate complex ideas in a manner that can be clearly communicated 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 to address challenges associated with life-cycle management and CMC activities.

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