Director, Toxicology/Nonclinical Research

The organization is seeking a Director-level toxicology leader to guide nonclinical development activities across programs targeting MASH. This individual will serve as the nonclinical function representative on program teams, overseeing toxicology and ADME/DMPK strategy for assets at various stages of development.

The ideal candidate is a hands-on toxicologist with deep industry experience who excels at integrating data, identifying gaps, and designing robust nonclinical plans that support regulatory submissions and clinical advancement. Title level (Associate Director or Director) will be determined based on experience and leadership capabilities.

Key Responsibilities

• Act as the nonclinical function lead on cross‑functional program teams, representing toxicology and ADME/DMPK in strategic and scientific decision-making.
• Develop and implement comprehensive nonclinical strategies to support IND-enabling and clinical-phase programs in MASH.
• Provide oversight for CRO-executed toxicology and ADME studies, including protocol development, study monitoring, data evaluation, and final reporting.
• Review and assess external nonclinical datasets from in-licensed or acquired programs, highlighting risks, data gaps, and mitigation approaches.
• Analyze toxicology, toxicokinetic, and ADME results to inform clinical dose selection, safety margins, and overall risk assessments.
• Contribute to writing, reviewing, and approving nonclinical components of regulatory submissions such as INDs, amendments, responses, and briefing materials.
• Collaborate closely with pharmacology, clinical development, regulatory affairs, CMC, and project management teams to ensure alignment and execution of program objectives.

• PhD (or equivalent) or Master's degree in Toxicology, Pharmacology, or a related scientific discipline.
• Approximately 12-15 years of pharmaceutical or biotechnology experience in nonclinical development.
• Strong background in ADME and/or DMPK preferred.
• Experience with late‑stage small‑molecule development required.
• Proven track record designing, executing, and interpreting nonclinical safety and ADME studies for IND and clinical development support.
• Demonstrated ability to manage outsourced studies and collaborate effectively with CROs.
• Excellent written and verbal communication skills, with the ability to work efficiently in cross-functional team settings.

This role may be offered at the Associate Director or Director level depending on the candidate's qualifications, leadership experience, and anticipated responsibilities.