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.