Vice President, Clinical Development Program Leader
Core
Senior clinical leader responsible for shaping, leading, and executing clinical strategy across one or more therapeutic programs from preclinical stages through registration.
Role type
Senior IC Vice President, Clinical Development Program Leader
Builds
Novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), specifically Rezdiffra (resmetirom)
Domain
Biopharmaceuticals / Liver disease (MASH) / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> clinical development plans and regulatory submissions
Required skills
Strategic clinical leadership, cross-functional program oversight, regulatory interaction management, translational medicine expertise, biomarker development, Phase I-IV trial oversight, IND/NDA/BLA filing experience, KOL engagement, team mentorship
Preferred skills
Board certification in Internal Medicine, Gastroenterology, Endocrinology, or Hepatology, experience with compensated MASH cirrhosis trials
Technologies
None explicitly listed (clinical/regulatory domain)
Responsibilities
Lead cross-functional program teams to shape product strategy and drive integrated development plans; Set program goals in collaboration with executive leadership; Lead creation of Clinical Development Plans (CDPs) from FIH through late-stage trials; Oversee design and medical oversight of FIH, SAD/MAD, translational, and PoC studies; Ensure high-quality medical monitoring and patient safety oversight; Lead early regulatory interactions (pre-IND, Scientific Advice, ITF meetings); Serve as senior clinical representative in global regulatory interactions (FDA, EMA, PMDA); Mentor and guide clinical scientists and cross-functional team members
Seniority
Executive (VP), hands-on strategic leadership