Vice President, Clinical Development Program Leader at Madrigal Pharmaceuticals in Conshohocken, PA

Job description

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. Vice President, Clinical Development Program Leader Company Background Madrigal Pharmaceuticals is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease with high unmet medical need. The company’s medication, Rezdiffra (resmetirom), is the first and only FDA and European Commission-approved treatment for MASH with moderate to advanced fibrosis. Madrigal’s pipeline includes ongoing Phase 3 trials and new assets in early development. Role Overview The Vice President, Clinical Development Program Leader is a senior clinical leader responsible for shaping, leading, and executing clinical strategy across one or more therapeutic programs. This role blends strategic clinical leadership, cross-functional program oversight, and hands-on execution from early development through registration. The VP will guide assets from preclinical stages through IND submission, first-in-human (FIH) studies, and late-stage development, ensuring scientific rigor, patient safety, and alignment with corporate priorities. Key Responsibilities Lead cross-functional program teams, shaping product strategy and driving integrated development plans. Transition from direct clinical oversight in early development to strategic leadership of a growing clinical team. Set program goals in collaboration with executive leadership, ensuring alignment across functions. Maintain accountability for program timelines, budget, and deliverables, aligning activities with portfolio management and internal reporting needs. Develop clinical and translational strategy for new assets, including Target Product Profile (TPP) definition, clinical hypotheses, and indication prioritization. Lead creation of Clinical Development Plans (CDPs) from FIH through Proof-of-Concept (PoC) and late-stage trials. Oversee design and medical oversight of FIH, SAD/MAD, translational, and PoC studies, as well as Phase I–IV trials. Ensure high-quality medical monitoring, patient safety oversight, and timely clinical decision-making. Lead early regulatory interactions (pre-IND, Scientific Advice, ITF meetings) and respond to regulatory feedback. Oversee development and medical accuracy of IND submissions, Investigator Brochures, and regulatory documentation. Serve as senior clinical representative in global regulatory interactions (FDA, EMA, PMDA, etc.). Support preparation and defense of regulatory submissions, including IND amendments, meeting packages, and marketing applications. Integrate clinical development, biostatistics, operations, CMC, regulatory, and safety functions for assigned programs. Partner with Translational Medicine, Nonclinical, CMC, Commercial, and Market Access teams to shape biomarker development, assay readiness, and patient stratification strategies. Foster robust cross-functio