Associate Director, Toxicology (Nonclinical Safety)

Location: San Francisco, California, United States; hybrid

Company

Biotechnology company advancing pipeline programs through research and development.

What you will do

• Lead nonclinical safety and toxicology strategy across discovery and development programs.
• Design, oversee, and monitor exploratory, IND-enabling, post-IND, safety pharmacology, reproductive, and carcinogenicity studies.
• Analyze nonclinical data, assess risk-benefit profiles, identify data gaps, and develop mitigation strategies.
• Manage CROs and external vendors, including study design, execution, and data quality.
• Author and review nonclinical sections of INDs, Investigator’s Brochures, briefing books, and responses to health authorities.
• Collaborate with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams on integrated development plans and portfolio decisions.

Requirements

• PhD in Toxicology, Pharmacology, or a related scientific discipline.
• Approximately 10+ years of industry experience in nonclinical safety or toxicology.
• Experience with IND-enabling and regulatory toxicology strategies.
• Strong knowledge of GLP regulations, ICH guidance, and regulatory expectations.
• Experience designing, monitoring, and interpreting nonclinical safety studies, including CRO oversight.
• Strong scientific judgment, communication, presentation, and cross-functional collaboration skills.

Nice to have

• DABT board certification.
• Experience supporting small molecule drug development programs.
• Experience with regulatory submissions and health agency interactions.
• Background in pain, neuroscience, or related therapeutic areas.
• Experience in early-stage biotechnology environments.

Culture & Benefits

• Hybrid work environment in San Francisco.
• Collaboration across multidisciplinary research, development, and regulatory functions.
• Opportunity to contribute to pipeline advancement and portfolio-level scientific decisions.