Associate Director / Director, Toxicology

Responsibilities:
- Work cross-functionally to drive nonclinical safety activities from discovery through regulatory filings and to commercialization for various programs.
- Develop and oversee phase-appropriate nonclinical safety strategies and integrated project plans (milestones, timelines, resources, budgets).
- Coordinate with CROs (with Nonclinical Development Operations) to ensure on-time delivery of study results and reports.
- Serve as subject matter expert for GLP, non-GLP, and safety pharmacology studies.
- Provide toxicology support for regulatory submissions and health authority interactions, including authoring nonclinical safety sections of US and international applications and resolving nonclinical safety queries.
- Drive delivery of high-quality safety reports for clinical plans and regulatory filings in multiple markets.
- Act as the toxicology representative in internal and external cross-functional meetings.

Qualifications:
- Ph.D. with 8+ years scientific experience OR MS with 12+ years OR BS with 15+ years in preclinical toxicology.
- Experience with LNPs and/or gene therapies.
- Ability to develop and deliver clear, concise presentations.
- In-depth understanding of nonclinical safety and experience with regulatory filings.
- Extensive knowledge of relevant FDA and EMEA regulations and processes.
- Proven experience working with CROs for protocol design and study execution.
- Experience with cross-functional/collaborative project teams.
- Onsite expectation: 1–3 days per week.