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