Senior Director, Nonclinical Toxicology and ADME

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

Position: Senior Director, Nonclinical Toxicology & ADME

Department: Research

Location: West Conshohocken

Reports to: Executive Director, Head of Research

Position Summary:

We are seeking a highly experienced and motivated Senior Director of Nonclinical Toxicology & ADME to join our dynamic team. This leadership role will be instrumental in driving the nonclinical drug development process, focusing on nonclinical candidate GLP toxicology as well as on the absorption, distribution, metabolism, and excretion (ADME) properties of new drug candidates. The successful candidate will have substantial experience as Study Director managing nonclinical studies hands-on, as a study director and through external Contract Research Organizations (CROs), with expertise in both non-GLP and GLP (Good Laboratory Practice) environments.

Key Responsibilities:

· Lead and manage nonclinical toxicology and ADME, providing scientific and strategic leadership in the design, execution, and interpretation of studies.

· Oversee the development and implementation of toxicology strategies as a Study Director to support the selection and optimization of drug candidates, as well as advancement of novel candidates to IND.

· Manage relationships with CROs, ensuring the successful outsourcing, execution, and quality control of toxicology studies in both non-GLP and GLP settings.

· Collaborate closely with cross-functional teams, including medicinal chemistry, pharmacology, clinical development, and regulatory affairs, to ensure alignment of outsourced toxicology and ADME studies with overall project goals.

· Interpret and integrate data from toxicology and ADME studies to assess the safety and efficacy profiles of drug candidates.

· Provide expert guidance on nonclinical toxicology and ADME aspects in the preparation of regulatory submissions (e.g., IND, NDA, MAA).

· Keep abreast of the latest advancements in toxicology, ADME, and drug metabolism, incorporating new approaches and technologies into the drug development process.

· Contribute to the overall strategy and direction of nonclinical development within the company.

Qualifications:

· Ph.D. in Toxicology, Pharmacokinetics or a related field.

· A minimum of 15 years of experience in nonclinical toxicology and ADME within the pharmaceutical or biotechnology industry.

· Must (or preferable to) have DABT (Diplomate of the American Board of Toxicology) certification.

· Extensive experience managing nonclinical studies through external CROs, with proven ability to oversee outsourced toxicology and ADME work in both non-GLP and GLP environments.

· Proven track record in leading and delivering successful drug development programs, with a strong understanding of the drug discovery and development process.

· Expertise in designing, executing, and interpreting ADME and toxicology studies.

· In-depth knowledge of regulatory requirements and guidelines for nonclinical safety assessment.

· Strong leadership and management skills, with the ability to inspire and guide a team of scientists.

· Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.

· Experience in metabolic disease drug development is highly desirable.

Preferred Qualifications:

· Experience with small molecules, biologics, or both.

· Familiarity with toxicology platforms including, in vitro toxicology and metabolic investigations, predictive and omics-based toxicology approaches and in vivo toxicology and pathology.

· Familiarity with emerging technologies in ADME, such as in vitro and in silico modeling, PKPB modeling, Phoenix WinNonlin, bioanalytical platforms, and in vitro cell based ADME platforms.

· Publications in peer-reviewed journals or presentations at scientific conferences in relevant fields.

Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, a