Associate Director, Toxicology
About The Position
We are seeking a highly motivated and experienced Associate Director of Toxicology (Nonclinical Safety) to support the advancement of our pipeline programs. This individual will play a key role in designing, executing, and interpreting nonclinical safety strategies across discovery and development programs. This role will contribute to research and development programs. The successful candidate will serve as a subject matter expert on cross-functional teams and contribute to regulatory strategy, ensuring that nonclinical programs are scientifically robust and aligned with development timelines.
Requirements
- PhD in Toxicology, Pharmacology, or related scientific discipline
- ~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
Nice To Haves
- DABT board certification is preferred
- Experience supporting regulatory submissions and agency interactions
- Background in pain, neuroscience, or related therapeutic areas
- Prior experience in early-stage biotech environments
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
