Director/Senior Director, Toxicology
$230,000–$300,000 year
Hybrid · San Francisco, California, United States
Job Summary
Director or Senior Director of Toxicology to lead nonclinical safety strategy across autoimmune pipeline. Lead design/oversight of GLP and non-GLP toxicology studies, manage CRO partnerships, author nonclinical sections of IND/IMPD submissions, interpret findings for clinical teams and health authorities, represent toxicology in cross-functional teams, and help build a best-in-class nonclinical safety function as the company scales. Requires Ph.D. in a related field with extensive industry experience and regulatory expertise in ICH guidelines.
Required Qualifications
- Ph.D. in Toxicology, Pharmacology, Pathology, or related discipline; board certification (DABT) strongly preferred
- 10+ years of industry experience in nonclinical safety, with a track record of advancing programs through IND filing and into clinical development
- Hands-on experience designing and managing GLP toxicology studies and CRO oversight
- Experience in immunology, inflammation, or autoimmune disease therapeutic areas strongly preferred; familiarity with immune-related adverse events and immunotoxicology is a plus
- Proven ability to author and defend nonclinical sections of regulatory submissions, including INDs and briefing documents
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