Associate Director of Toxicology (Nonclinical Safety)

Location: San Francisco, California (Hybrid)

Company

hirify.global is advancing pipeline programs through research and development.

What you will do

• Serve as the nonclinical safety and toxicology subject matter expert on multidisciplinary project teams.
• Design, oversee, and monitor exploratory, non-GLP, IND-enabling, post-IND, reproductive, chronic, sub-chronic, carcinogenicity, and safety pharmacology studies.
• Manage CROs and external vendors, including study design, execution, and data quality.
• Analyze and interpret nonclinical data, evaluate risk/benefit profiles, identify data gaps, and develop mitigation strategies.
• Author and review nonclinical sections of INDs, Investigator’s Brochures, briefing books, and responses to health authorities.
• Partner with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams on integrated development plans, timelines, 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 scientific judgment, problem-solving, communication, and presentation skills.
• Ability to work effectively in cross-functional, fast-paced environments with a collaborative, proactive, and detail-oriented approach.
• Strong knowledge of GLP regulations, ICH guidance, and regulatory expectations.
• Experience designing, monitoring, and interpreting nonclinical safety studies.
• Familiarity with CRO oversight and external vendor management.

Nice to have

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

Culture & Benefits

• Hybrid work arrangement in San Francisco, California.
• Cross-functional collaboration across Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams.
• Opportunity to contribute to research and development programs and portfolio-level decision-making.