Associate Director, Toxicology

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.
Key Responsibilities:
Nonclinical Strategy & Leadership
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
Study Design & Execution
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
Data Analysis & Interpretation
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
Regulatory Support
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
Cross-Functional Collaboration
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
Education & Experience
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
Core Competencies
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
Technical Skills
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
Preferred Qualifications
Experience supporting regulatory submissions and agency interactions
Background in pain, neuroscience, or related therapeutic areas
Prior experience in early-stage biotech environments

Employment type
Full-Time

Work arrangement
No