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.

Responsibilities

• 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.

Qualifications

• 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.