Director, Clinical Pharmacology

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

We are seeking a highly skilled and motivated Clinical Pharmacologist to join our dynamic research and development team. The ideal candidate will have also have experience in the application of model-informed drug development (MIDD) to predict drug behavior, optimize dosing, and improve therapeutic outcomes. Knowledge of bioanalytical guidelines, methods, and their assessment is also a plus. This position offers the opportunity to contribute to the development of innovative therapies in a growing pharmaceutical company focused on helping patients with metabolic dysfunction-associated steatohepatitis (MASH) and related metabolic diseases, and to work in a collaborative environment with a commitment to scientific excellence. This role potentially includes the optimization and implementation of clinical pharmacology plans, incorporating established and innovative approaches, to help advance early development programs through IND / clinical POC, late-stage development programs through NDA, BLA and MAA, and post approval activities. In this role, you will apply modeling and simulation techniques to support drug development, dose optimization, and regulatory submissions. Collaboration with cross-functional teams, including research scientists, clinical leads, medical writers, and regulatory experts, will be essential to integrate planning and analyses into overall drug development strategies. Additionally, you will contribute to the preparation of regulatory submissions, scientific publications, and presentations at scientific conferences.

Position Specific Responsibilities:

• Responsible for Clinical Pharmacology strategy within their projects
• Represent Clinical Pharmacology and contribute to integrated strategy on development teams, at governance meetings, and in regulatory engagement with health authorities.
• Serve as a Clinical Pharmacology subject matter expert. Develop, review, and approve Clinical Pharmacology scientific content and conclusions across relevant company documents and activities.
• Support strategy for dose selection, dose justification, and regulatory filings.
• Assess and inform bioanalytical planning and methods
• Lead design of Clinical Pharmacology studies and associated data analysis, interpretation, and reporting
• Provide input to Phase 1-4 clinical study design and registrational strategy
• Develops and execute model-informed drug development (MIDD) strategy, both through hands-on work and managing vendors
• Provide critical expertise to Business Development teams to assess external opportunities

Specialized Knowledge & Skills:

• Demonstrated ability to work in a dynamic team-oriented environment
• Demonstrated stakeholder management with strong influence/leadership
• Quantitative data analysis and data visualization skills
• Experience programming and using data analysis and modeling tools (e.g., NONMEN, R, MATLAB, Monolix, Simcyp, GastroPlus, Phoenix WinNonlin, etc.)
• Demonstrated proficiency in one or more model informed drug development (MIDD) principles and analyses, including PopPK/PD, E-R, PBPK, QSP, MBMA
• Knowledgeable about bioanalytical methods, guidances, and issues commonly encountered is a plus
• A commitment to working as a team player and helping to establish new, optimal best practices and processes for high quality Clinical Pharmacology deliverables

Educational Requirements:

• Advanced Degree in pharmacology, pharmaceutical sciences, chemical/biomedical engi