Job Description

Job Description

Job Description

Principal 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

Job Tags

Similar Jobs