Job Description
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.
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