Senior Medical Director, Translational Medicine & Early Clinical Development
Madrigal Pharmaceuticals
June 30, 2026
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Senior Medical Director, Translational Medicine & Early Clinical Development
Key Responsibilities
Clinical study leadership
- Serve as global medical lead/medical monitor for early phase studies (e.g., FIH, PoC, mechanistic, and indication-expansion trials in MASH and related cardiometabolic/liver conditions).
- Lead design of study concepts and protocols, including patient populations, endpoints (clinical/biomarker), and mechanistic sub-studies.
- Provide ongoing medical oversight (eligibility review, safety monitoring, dose decision-making, interpretation of emerging data).
- Partner with Clinical Operations and CROs to ensure high-quality execution, timely delivery of data, and inspection-readiness.
Translational and biomarker strategy
- Define and own translational strategy for assigned programs (preclinical to late-stage), ensuring alignment between nonclinical and clinical plans.
- Integrate PK/PD, biomarkers, imaging, and clinical outcomes to build a mechanistic narrative and inform dose/regimen selection.
- Oversee clinical biomarker plans for early/mechanistic studies with Research, Biomarkers, and external labs/CROs.
- Drive biospecimen banking and downstream analyses.
Cross-functional leadership and governance
- Chair/co-chair early asset teams/translational working groups (objectives, deliverables, decision points).
- Partner with Clinical Development, Clinical Pharmacology, Regulatory Affairs, Biostatistics, Safety, and Commercial.
- Provide input to key documents (IB, CSR, TS/TPPs, regulatory briefing materials, publications, presentations).
- Present work at governance forums and, as appropriate, to the Executive Team/Board.
External engagement
- Build relationships with external experts; lead/co-lead collaborations with academics/consortia.
- Represent the company at scientific/medical conferences.
People and capability building
- Provide day-to-day leadership/mentoring for junior physicians and PhD scientists.
- Refine the operating model for Translational Medicine (interfaces with Research and Clinical Development).
Qualifications
- MD with clinical training in a relevant specialty (e.g., hepatology, gastroenterology, endocrinology, cardiology, internal medicine) or equivalent.
- 15+ years relevant industry experience in clinical development, including leadership of early phase interventional trials.
- Strong translational medicine and biomarker-driven development track record; metabolic liver or cardiometabolic disease experience strongly preferred.
- Regulatory interaction experience on early development/biomarker topics highly desirable.
- Ability to lead cross-functional teams, influence without authority, and operate effectively in a growing organization.
- Excellent communication skills, including articulating complex mechanistic concepts to diverse stakeholders.
Key Responsibilities
Clinical study leadership
- Serve as global medical lead/medical monitor for early phase studies (e.g., FIH, PoC, mechanistic, and indication-expansion trials in MASH and related cardiometabolic/liver conditions).
- Lead design of study concepts and protocols, including patient populations, endpoints (clinical/biomarker), and mechanistic sub-studies.
- Provide ongoing medical oversight (eligibility review, safety monitoring, dose decision-making, interpretation of emerging data).
- Partner with Clinical Operations and CROs to ensure high-quality execution, timely delivery of data, and inspection-readiness.
Translational and biomarker strategy
- Define and own translational strategy for assigned programs (preclinical to late-stage), ensuring alignment between nonclinical and clinical plans.
- Integrate PK/PD, biomarkers, imaging, and clinical outcomes to build a mechanistic narrative and inform dose/regimen selection.
- Oversee clinical biomarker plans for early/mechanistic studies with Research, Biomarkers, and external labs/CROs.
- Drive biospecimen banking and downstream analyses.
Cross-functional leadership and governance
- Chair/co-chair early asset teams/translational working groups (objectives, deliverables, decision points).
- Partner with Clinical Development, Clinical Pharmacology, Regulatory Affairs, Biostatistics, Safety, and Commercial.
- Provide input to key documents (IB, CSR, TS/TPPs, regulatory briefing materials, publications, presentations).
- Present work at governance forums and, as appropriate, to the Executive Team/Board.
External engagement
- Build relationships with external experts; lead/co-lead collaborations with academics/consortia.
- Represent the company at scientific/medical conferences.
People and capability building
- Provide day-to-day leadership/mentoring for junior physicians and PhD scientists.
- Refine the operating model for Translational Medicine (interfaces with Research and Clinical Development).
Qualifications
- MD with clinical training in a relevant specialty (e.g., hepatology, gastroenterology, endocrinology, cardiology, internal medicine) or equivalent.
- 15+ years relevant industry experience in clinical development, including leadership of early phase interventional trials.
- Strong translational medicine and biomarker-driven development track record; metabolic liver or cardiometabolic disease experience strongly preferred.
- Regulatory interaction experience on early development/biomarker topics highly desirable.
- Ability to lead cross-functional teams, influence without authority, and operate effectively in a growing organization.
- Excellent communication skills, including articulating complex mechanistic concepts to diverse stakeholders.