Vice President, Clinical Development Program Leader
About The Position
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. 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.
Requirements
- MD or DO; board certification in a relevant specialty (Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related field) preferred.
- 10–15+ years of clinical development experience, including significant leadership of early-phase and late-stage programs, with 20+ years of total relevant experience.
- Proven success in leading clinical programs across all development phases, including regulatory filings (INDs/NDAs/BLAs), launch, and commercialization.
- Strong background in translational medicine, biomarkers, and early-phase PK/PD.
- Demonstrated success leading pre-IND and IND interactions with global regulatory agencies.
- Extensive experience working in matrixed, global teams, with the ability to influence across functions without direct reporting lines.
- Deep understanding of the commercial landscape, regulatory strategy, and CMC considerations relevant to drug development.
- Strategic clinical leadership and ability to create strategy from incomplete data.
- Translational and hypothesis-driven thinking.
- Cross-functional integration and collaboration.
- Scientific rigor and disciplined decision-making.
- Organizational leadership and talent development.
- External engagement and influence.
- Strong clinical judgment, communication, and ethical conduct.
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-functional collaboration, scenario planning, and contingency strategies.
- Build and maintain relationships with KOLs, investigators, scientific advisors, and development partners.
- Represent Madrigal at scientific meetings, advisory boards, and collaborative consortia.
- Support scientific publication and external communication strategies.
- Mentor and guide clinical scientists and cross-functional team members.
- Contribute to building early-development capabilities, frameworks, processes, and scalable best practices.
- Foster a culture of openness, trust, and scientific integrity.
Benefits
- flexible paid time off
- medical, dental, vision and life/disability insurance
- 401(k) offerings (i.e., traditional, Roth, and employer match)
- supplemental life insurance
- legal services
- mental health benefits through our Employee Assistance Program
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
