Senior Medical Director, Early Clinical Development & Translational Medicine (MD)
Description
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.
The Senior Medical Director, Early Clinical Development & Translational Medicine (MD ) is an experienced clinical development physician responsible for leading first-in-human and early-phase clinical programs and shaping translational strategy across Madrigal’s metabolic liver and cardiometabolic portfolio.
This role requires substantial hands-on industry Clinical Development experience, including direct medical leadership of Phase 1 and early Phase 2 interventional studies. The individual will serve as medical lead and medical monitor for first-in-human, proof-of-concept, mechanistic, and indication-expansion studies, integrating clinical, biomarker, pharmacologic, and mechanistic data to inform dose selection, go/no-go decisions, subsequent development strategy, and lifecycle opportunities.
The role will be a key member and often chair of early asset/program teams and a close partner to Research, Clinical Development, Clinical Pharmacology, Biostatistics, Regulatory Affairs, and Safety.
Key Responsibilities
Clinical Study Leadership
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Serve as global medical lead and medical monitor for early-phase interventional studies, including first-in-human, Phase 1/1b, early proof-of-concept, mechanistic, and indication-expansion trials in MASH and related cardiometabolic/liver conditions.
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Lead development of study concepts and protocols, including selection of patient populations, clinical and biomarker endpoints, dose-escalation/selection strategy, and mechanistic sub-studies.
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Provide hands-on medical oversight throughout study execution, including eligibility review, safety monitoring, dose decisions, benefit-risk assessment, and interpretation of emerging clinical data.
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Translate emerging clinical, safety, pharmacologic, and biomarker data into actionable program decisions and recommendations for subsequent development.
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Partner with Clinical Operations and CROs to ensure high-quality study execution, timely delivery of data, and inspection readiness.
Translational and Biomarker Strategy
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Lead the clinical and translational strategy for assigned early-development programs, translating preclinical evidence into executable clinical development plans and integrating emerging human data to guide subsequent development.
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Integrate pharmacokinetic, pharmacodynamic, biomarker, imaging, and clinical outcome data to establish proof-of-mechanism, inform dose/regimen selection, and support development decisions.
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Integrate clinical biomarker strategy into early clinical development plans in close partnership with Research, Biomarkers, Clinical Pharmacology, and external laboratories/CROs.
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Guide biospecimen collection and downstream analyses to enable mechanistic understanding and future exploratory work.
Cross-Functional Leadership and Governance
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Serve as the accountable physician and chair or co-chair early asset/program teams and translational working groups, establishing objectives, deliverables, decision points, and development recommendations.
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Partner with Research, Clinical Development, Clinical Pharmacology, Regulatory Affairs, Biostatistics, Safety, Clinical Operations, and Commercial to ensure an integrated development strategy.
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Provide clinical and mechanistic leadership for key development documents, including Investigator’s Brochures, Clinical Study Reports, target product profiles, regulatory briefing materials, publications, and presentations.
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Present clinical development strategy, emerging data, and program recommendations at internal governance forums and, where appropriate, to the Executive Team and Board.
External and Regulatory Engagement
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Contribute to and participate in regulatory interactions related to early clinical development, including clinical development strategy, study design, dose selection, safety, and biomarker approaches.
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Build and maintain relationships with key external experts in MASH, cardiometabolic disease, and relevant imaging/biomarker fields.
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Lead or co-lead scientific collaborations with academic groups and consortia to address mechanistic questions and support development strategy.
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Represent the company at scientific and medical conferences, including presenting clinical and translational results.
People and Capability Building
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Provide day-to-day leadership and mentoring for junior physicians and PhD scientists within Translational Medicine/Early Clinical Development.
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Help refine and evolve the operating model for Translational Medicine and Early Clinical Development, including interfaces with Research and broader Clinical Development.
Qualifications
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MD with clinical training in a relevant specialty (e.g., hepatology, gastroenterology, endocrinology, cardiology, internal medicine) or equivalent.
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15+ years relevant and industry experience in clinical development, including demonstrable leadership of early phase interventional trials.
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Direct experience leading first-in-human and/or Phase 1 clinical studies is required , including protocol design, medical monitoring, safety assessment, dose-escalation/selection decisions, and interpretation of emerging clinical data.
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Demonstrated experience serving as the accountable physician and/or Clinical Development Lead for early-stage assets, with direct responsibility for clinical development strategy and study execution.
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Strong track record integrating PK/PD, biomarkers, and mechanistic data into clinical development decisions , including dose selection, proof-of-mechanism, proof-of-concept, and go/no-go decisions.
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A sustained track record of direct industry Clinical Development leadership is required in addition to scientific, academic, or Medical Affairs experience.
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Strong track record in translational medicine and biomarker-driven development; experience in metabolic liver or cardiometabolic disease strongly preferred.
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Experience interacting with regulatory agencies on early development and biomarker topics is highly desirable.
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Demonstrated ability to lead cross-functional teams, influence without authority, and operate effectively in a growing, evolving organization.
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Excellent communication skills, with the ability to articulate complex clinical and mechanistic concepts to diverse stakeholders, including researchers, clinicians, executives, and board members.
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Hybrid opportunity (3 days per week in office) based in our Conshohocken, PA or Waltham, MA offices.
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. Full-time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs, and ma