Madrigal Pharmaceuticals

Vice President, Clinical Development Program Leader (MD)

PA - Conshohocken - Office, USA · Exec · Full-time

Sponsorship not specified$10k-$15kDetected 27 days ago

Product StrategyCompensationFDA RegulatoryAnimal StudiesLeadershipCommunicationCollaborationBiostatistics

About the role

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.

Lead cross-functional program teams, shaping product strategy and driving integrated development plans.
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.
Lead early regulatory interactions (pre-IND, Scientific Advice, ITF meetings) and respond to regulatory feedback.
Support preparation and defense of regulatory submissions, including IND amendments, meeting packages, and marketing applications.
Partner with Translational Medicine, Nonclinical, CMC, Commercial, and Market Access teams to shape biomarker development, assay readiness, and patient stratification strategies.
Build and maintain relationships with KOLs, investigators, scientific advisors, and development partners.
Support scientific publication and external communication strategies.
Contribute to building early-development capabilities, frameworks, processes, and scalable best practices.

board certification in a relevant specialty (Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related field) preferred.

Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity.

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.

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.

This listing is sourced directly from Madrigal Pharmaceuticals's careers page and normalized into a canonical job model.