Director, Nonclinical Development

Responsibilities and Duties

• Develop and execute integrated nonclinical development strategies (toxicology, DMPK, and ADME) supporting programs from IND-enabling through early and late clinical development, including Phase 3 and NDA planning.
• Serve as the nonclinical development lead on cross-functional program teams, providing scientific input to development strategy, risk assessment, and decision-making across multiple programs.
• Assess nonclinical data packages, identify gaps and risks, and propose mitigation strategies aligned with ICH guidelines, GLP regulations, and evolving global regulatory expectations.
• Propose, design, and oversee nonclinical toxicology, DMPK, and ADME studies at external CROs (GLP and non-GLP), providing scientific oversight of protocols, execution, data interpretation, and final reports, and managing CRO relationships, timelines, and budgets.
• Provide scientific leadership for mechanism-based safety assessment, integrating safety data to inform translational and clinical plans.
• Author, review, and/or substantially contribute to nonclinical sections of regulatory documents, including INDs, IBs, DSURs, NDAs, and other marketing applications, and partner closely with Regulatory Affairs to support health-authority interactions.
• Support preparation for regulatory agency meetings and responses to regulatory questions, with experience representing toxicology/nonclinical functions in interactions with global health authorities (e.g., FDA, EMA).
• Synthesize complex nonclinical data into clear, coherent narratives to support internal decision-making, regulatory filings, and external communications with partners and due-diligence stakeholders.
• Collaborate closely with Clinical Development, Regulatory Affairs, CMC, and Project Management to ensure alignment of nonclinical plans with overall development strategy.
• Operate effectively in a dynamic startup environment, demonstrating flexibility, agility, and the ability to rapidly learn, adapt, and contribute to the evolution of nonclinical standards and ways of working across the organization.

Qualifications and Skills

• PhD, DVM, or equivalent advanced degree in Toxicology, Pharmacology, or a related scientific discipline.
• 10+ years industry experience in nonclinical development within pharmaceutical or biotechnology organizations.
• Deep expertise in toxicology, with strong working knowledge of DMPK and ADME.
• Proven experience delivering nonclinical data packages to support IND-enabling and clinical-stage programs.
• Demonstrated authorship or major contribution to key regulatory documents, including INDs and Investigator’s Brochures.
• Extensive experience designing and managing outsourced nonclinical studies and working effectively with CROs.
• Strong written and verbal communication skills, with the ability to synthesize and explain complex data clearly.