Associate Director, Toxicology

Key Responsibilities

• Serve as the nonclinical safety/toxicology subject matter expert on multidisciplinary project teams
• Provide integrated assessments of nonclinical data and evaluate overall risk/benefit profiles
• Contribute to development candidate selection and overall program strategy
• Design, oversee, and monitor nonclinical safety studies, including: exploratory/non-GLP toxicology studies, IND-enabling toxicology and safety pharmacology studies, post-IND studies (e.g., sub-chronic, chronic, reproductive, carcinogenicity)
• Manage and oversee CROs and external vendors, including study design, execution, and data quality
• Analyze and interpret nonclinical study data to support program decisions
• Prepare and present findings, and provide guidance to internal stakeholders and governance teams
• Identify data gaps and proactively develop mitigation strategies
• Author and review nonclinical sections of regulatory documents, including: INDs, Investigator’s Brochures (IBs), Briefing books, and responses to health authorities
• Partner with Regulatory Affairs to support interactions with agencies (e.g., FDA)
• Ensure compliance with GLP, ICH, and applicable regulatory guidelines
• Work closely with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams
• Contribute to integrated development plans and timelines
• Support portfolio-level decision-making through scientific insight

Qualifications

• PhD in Toxicology, Pharmacology, or related scientific discipline
• DABT board certification is preferred
• ~10+ years of industry experience in nonclinical safety/toxicology
• Experience supporting small molecule drug development programs preferred
• Experience with IND-enabling and regulatory toxicology strategies required
• Strong scientific judgment and problem-solving capabilities
• Excellent communication and presentation skills
• Ability to work effectively in cross-functional, fast-paced environments
• Collaborative, proactive, and detail-oriented mindset
• 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