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
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Serve as the toxicology lead on multidisciplinary teams, developing and executing non-clinical safety strategies for new therapeutic candidates.
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Evaluate potential safety and toxicity risks across programs from early discovery through regulatory filing.
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Design and oversee non-clinical safety studies to assess relevance and translatability of findings to humans.
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Manage internal and external study execution, including CRO oversight, protocol development, monitoring, and data interpretation.
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Collaborate closely with cross-functional teams such as Biology, Biomarkers, and PK/PD to integrate non-clinical and translational insights into development plans.
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Draft and review non-clinical sections of regulatory submissions, including INDs, IMPDs, CTAs, and Investigators Brochures.
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Participate in regulatory interactions with agencies such as the FDA, EMA, and PMDA to discuss non-clinical strategy and data packages.
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Manage external vendor relationships, budgets, and timelines, ensuring compliance with applicable regulations.
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Lead, mentor, and develop a team of toxicologists, fostering scientific rigor, collaboration, and professional growth.
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Contribute to publications, presentations, and scientific engagement with external stakeholders and the broader research community.
Qualifications
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PhD or MS in Toxicology, Pharmacology, Pathology, or a related field; post-doctoral experience preferred.
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10+ years of experience in non-clinical or regulatory toxicology (15+ years for MS-level candidates).
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Experience with biologics and/or oligonucleotide-based therapeutics preferred.
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Strong understanding of GLP regulations and global regulatory guidelines (FDA, EMA, ICH).
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Demonstrated success managing CRO relationships, toxicology studies, and regulatory submissions.
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Proven ability to influence cross-functional teams and operate effectively in a matrixed organization.
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Excellent communication, presentation, and leadership skills with a collaborative, solution-oriented mindset.
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Ability to work independently, prioritize multiple projects, and thrive in a fast-paced research environment.