Director, Toxicology, Non-clinical Development

Job Summary

The Director, Non-Clinical Development will lead a team of toxicologists supporting programs across research and development, providing scientific and strategic leadership for non-clinical safety evaluation from discovery through late-stage development. This role will define and implement non-clinical development strategies, oversee toxicology studies, and ensure high-quality data generation to support regulatory submissions and clinical advancement. The position requires strong collaboration in a matrixed environment and direct engagement with senior leadership, regulatory authorities, and cross-functional partners.

Key Responsibilities

• Serve as the toxicology lead on multidisciplinary teams, developing and executing non-clinical safety strategies for new therapeutic candidates.

• Evaluate potential safety and toxicity risks across programs from early discovery through regulatory filing.

• Design and oversee non-clinical safety studies to assess relevance and translatability of findings to humans.

• Manage internal and external study execution, including CRO oversight, protocol development, monitoring, and data interpretation.

• Collaborate closely with cross-functional teams such as Biology, Biomarkers, and PK/PD to integrate non-clinical and translational insights into development plans.

• Draft and review non-clinical sections of regulatory submissions, including INDs, IMPDs, CTAs, and Investigators Brochures.

• Participate in regulatory interactions with agencies such as the FDA, EMA, and PMDA to discuss non-clinical strategy and data packages.

• Manage external vendor relationships, budgets, and timelines, ensuring compliance with applicable regulations.

• Lead, mentor, and develop a team of toxicologists, fostering scientific rigor, collaboration, and professional growth.

• Contribute to publications, presentations, and scientific engagement with external stakeholders and the broader research community.

Qualifications

• PhD or MS in Toxicology, Pharmacology, Pathology, or a related field; post-doctoral experience preferred.

• 10+ years of experience in non-clinical or regulatory toxicology (15+ years for MS-level candidates).

• Experience with biologics and/or oligonucleotide-based therapeutics preferred.

• Strong understanding of GLP regulations and global regulatory guidelines (FDA, EMA, ICH).

• Demonstrated success managing CRO relationships, toxicology studies, and regulatory submissions.

• Proven ability to influence cross-functional teams and operate effectively in a matrixed organization.

• Excellent communication, presentation, and leadership skills with a collaborative, solution-oriented mindset.

• Ability to work independently, prioritize multiple projects, and thrive in a fast-paced research environment.