Director, Nonclinical Research

Role Summary

Madrigal Pharmaceuticals is seeking a Director to provide scientific and strategic leadership for nonclinical development programs supporting metabolic dysfunction–associated steatohepatitis (MASH). This role will serve as the nonclinical development line function lead on cross‑functional program teams representing toxicology and ADME for assets across different stages of development. This position requires a hands‑on toxicologist who can rapidly assess existing nonclinical data, identify gaps, and design and oversee toxicology and ADME/DMPK strategies to support regulatory submissions and clinical development.

This role is ideal for a toxicologist with strong industry experience who thrives in a collaborative, fast‑paced environment.

• Serve as the nonclinical development line function lead on program teams, representing toxicology and ADME/DMPK in cross‑functional decision‑making.
• Develop and execute integrated nonclinical development strategies to support IND‑enabling and clinical‑stage programs in MASH.
• Provide scientific oversight of CRO‑conducted studies, including protocol development, study monitoring, data review, interpretation, and reporting.
• Evaluate externally generated nonclinical data from acquired programs, identifying gaps, risks, and mitigation strategies.
• Interpret toxicology, toxicokinetic, and ADME data to support clinical dose selection, safety margins, and risk assessment.
• Contribute to the preparation, review, and approval of nonclinical sections of regulatory submissions, including INDs, amendments, and briefing packages.
• Partner closely with colleagues in pharmacology, clinical development, regulatory affairs, CMC, and project management to ensure alignment of nonclinical plans with program objectives and timelines.

• PhD (or equivalent) or Masters in Toxicology, Pharmacology, or a related scientific discipline.
• 12-15 years of relevant pharmaceutical or biotechnology industry experience in nonclinical development.
• ADME and/or DMPK experience strongly preferred.
• Late‑stage small molecule development experience required.
• Demonstrated experience designing and overseeing nonclinical safety and ADME studies to support INDs and clinical development.
• Experience managing outsourced studies and working effectively with CROs and external partners.
• Strong written and verbal communication skills and ability to work effectively on cross‑functional teams.