Job Description
Job DescriptionPrincipal Scientist, Preclinical Toxicology
Location: San Diego, CA | Full-time
Summary
We are seeking a senior-level toxicologist to lead and oversee GLP-compliant preclinical toxicology programs supporting IND, NDA, and BLA submissions. This role is ideal for a highly experienced Study Director with strong regulatory expertise and the ability to balance CRO service delivery with sponsor-driven drug development goals.
Responsibilities
- Serve as Study Director for GLP in vivo and in vitro toxicology studies
- Design, oversee, and interpret toxicology studies aligned with FDA, ICH, and international regulatory expectations
- Act as the primary scientific and client-facing lead for preclinical toxicology programs
- Integrate toxicology, pathology, and clinical pathology data into defensible regulatory conclusions
- Author, review, and approve final study reports and nonclinical regulatory content
- Support IND, NDA, and BLA submissions and participate in FDA-facing interactions as needed
- Ensure GLP compliance and represent the organization during audits and inspections
- Coordinate cross-functionally to ensure timelines, data integrity, and scientific rigor
Qualifications
- PhD in Toxicology, Pharmacology, or related discipline
- 5–7+ years of experience directing GLP toxicology studies, preferably in a CRO environment
- Proven track record as Study Director on completed GLP studies supporting regulatory submissions
- Direct experience contributing to IND/NDA/BLA nonclinical packages
- Strong understanding of FDA expectations and regulatory strategy
- DABT certification strongly preferred
Why Join
- Senior scientific leadership role with high impact on drug development programs
- Opportunity to guide complex preclinical toxicology strategies
- Collaborative, science-driven environment supporting innovative therapeutics