Job Description

Job Description

Job Description

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

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