Vice President, Clinical Development Program Leader (MD)
Core
Senior clinical leader shaping and executing clinical strategy for novel therapeutics targeting metabolic dysfunction-associated steatohepatitis (MASH), guiding assets from preclinical stages through registration.
Role type
Vice President, Clinical Development Program Leader (MD)
Builds
Novel therapeutics for MASH, specifically Rezdiffra (resmetirom) and future assets
Domain
Biopharmaceuticals / Hepatology / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic clinical leadership, Translational medicine expertise, Global regulatory interaction, Cross-functional integration, Program management, Clinical trial oversight, Biomarker strategy, IND/NDA/BLA filing experience, KOL engagement, Team mentorship
Preferred skills
Board certification in Internal Medicine, Gastroenterology, Endocrinology, or Hepatology, Experience with Phase I–IV trials, Deep understanding of CMC considerations
Technologies
None stated
Responsibilities
Lead cross-functional program teams to shape product strategy and drive integrated development plans; Set program goals in collaboration with executive leadership; Maintain accountability for program timelines, budget, and deliverables; Develop clinical and translational strategy including Target Product Profile definition; Lead creation of Clinical Development Plans from FIH through late-stage trials; Oversee design and medical oversight of FIH, SAD/MAD, translational, and Phase I–IV trials; Ensure high-quality medical monitoring and patient safety oversight; Lead early regulatory interactions and respond to feedback; Oversee development of regulatory documentation; Represent company in global regulatory interactions; Partner with Translational Medicine, Nonclinical, CMC, and Commercial teams; Mentor clinical scientists and cross-functional team members.
Seniority
Executive (VP), hands-on strategic leadership
