Madrigal Pharmaceuticals

Senior Director, Clinical Development (MD)

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

Sponsorship not specified$330k-$403kDetected 27 days ago

Clinical TrialsFDA RegulatoryExperimental DesignLeadershipCollaboration

About the role

Every member of our Madrigal team is connected by our shared purpose: leading the fight against 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).

Lead and oversee integrated Clinical Development Plans (CDPs) from early clinical development through registration and lifecycle management.
Clinical Strategy & Study Design
Partner with Clinical Operations to ensure operational excellence, enrollment strategy optimization, and proactive issue resolution.
Partner with Translational Medicine to refine biomarker strategies, patient stratification approaches, and mechanism-based differentiation.
Collaborate with Nonclinical and CMC teams to support safety packages, manufacturing readiness, and lifecycle planning.

MD or MD/PhD required
10+ years of clinical development experience across the drug development life cycle with 15+ years of total relevant experience.
Effective communicator with strong leadership presence and ability to influence internal and external stakeholders.
Experience in liver disease, MASH/NASH, metabolic disorders, cardiometabolic disease, inflammation, or endocrine pathways.
Experience supporting or leading NDA/MAA submissions and/or outcomes studies.
Experience advancing programs from early development through registration in a biotech setting.

Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package.

Serve as the medical voice for assigned programs at governance forums and executive leadership meetings.
Lead design and medical oversight of Phase I-III clinical trials, including FIH, PoC, registrational, and outcomes studies.
Provide medical oversight for ongoing clinical trials, ensuring patient safety, data integrity, and high-quality execution.
Review emerging data, conduct benefit-risk assessments, and guide adaptive development strategies as needed.
Serve as Clinical Development subject matter expert regulatory interactions globally (FDA, EMA, and other health authorities), including End-of-Phase meetings, Scientific Advice, and pre-NDA/MAA engagements.
Oversee the medical content and strategic framing of INDs, amendments, briefing books, Investigator Brochures, CSRs, and NDA/MAA submissions.

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.