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About the Role

This role supports pipeline program advancement by designing, executing, and interpreting nonclinical safety strategies across discovery and development. The individual will serve as a subject matter expert on cross-functional teams, contributing to regulatory strategy and ensuring scientifically robust nonclinical programs aligned with development timelines.

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, IND-enabling, safety pharmacology, and post-IND studies
• 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

Requirements

• Experience supporting small molecule drug development programs preferred
• Experience with IND-enabling and regulatory toxicology strategies required
• Experience supporting regulatory submissions and agency interactions
• Background in pain, neuroscience, or related therapeutic areas
• Prior experience in early-stage biotech environments

Skills

• 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

Experience Level

• ~10+ years of industry experience in nonclinical safety/toxicology

Education Level

• PhD in Toxicology, Pharmacology, or related scientific discipline
• DABT board certification is preferred