Senior Director, Clinical Development (MD)
Madrigal Pharmaceuticals
August 12, 2026
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Senior Director, Clinical Development
Responsibilities
- Provide strategic clinical leadership across 3 clinical-stage programs and 17 active studies.
- Lead and oversee integrated Clinical Development Plans (CDPs) from early development through registration and lifecycle management.
- Establish development milestones, go/no-go criteria, and risk mitigation strategies.
- Serve as the medical voice for assigned programs at governance and executive meetings.
- Lead design and medical oversight of Phase I–III trials (FIH, PoC, registrational, and outcomes).
- Define clinical endpoints, biomarker strategies, patient populations, statistical assumptions, and differentiation strategy.
- Integrate translational, PK/PD, and biomarker data into dosing and clinical decisions.
- Provide medical oversight for ongoing trials (patient safety, data integrity, execution quality).
- Partner with Clinical Operations on enrollment strategy, operational excellence, and issue resolution.
- Review emerging data, conduct benefit–risk assessments, and guide adaptive development.
- Contribute to safety governance and data monitoring.
- Lead global regulatory interactions (FDA/EMA/others) including End-of-Phase, Scientific Advice, and pre-NDA/MAA engagements.
- Oversee medical content for INDs/amendments/briefing books/IBs/CSRs and NDA/MAA submissions.
- Anticipate regulatory risks and incorporate evolving guidance.
- Collaborate cross-functionally with Translational Medicine, Nonclinical, CMC, Biometrics, Commercial, and HEOR; other duties as assigned.
Required Qualifications
- MD or MD/PhD; board certification in Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related field.
- 10+ years clinical development experience (drug development lifecycle) and 15+ years total relevant experience.
- Demonstrated success with health authority interactions.
- Proven ability to design clinical trials and make benefit-risk decisions with limited data.
- Effective communicator with leadership presence; can influence internal/external stakeholders.
Preferred Qualifications
- Experience in liver disease, MASH/NASH, metabolic disorders, cardiometabolic disease, inflammation, or endocrine pathways.
- Experience supporting/leading NDA/MAA submissions and/or outcomes studies.
- Experience advancing programs from early development through registration in a biotech setting.
Benefits
- Full-time employees receive base pay/bonus/equity and comprehensive benefits; full-time benefits include flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) (traditional, Roth, and employer match).
Application Instructions
- Applications accepted on an ongoing basis; submit through the Madrigal Careers site.
Responsibilities
- Provide strategic clinical leadership across 3 clinical-stage programs and 17 active studies.
- Lead and oversee integrated Clinical Development Plans (CDPs) from early development through registration and lifecycle management.
- Establish development milestones, go/no-go criteria, and risk mitigation strategies.
- Serve as the medical voice for assigned programs at governance and executive meetings.
- Lead design and medical oversight of Phase I–III trials (FIH, PoC, registrational, and outcomes).
- Define clinical endpoints, biomarker strategies, patient populations, statistical assumptions, and differentiation strategy.
- Integrate translational, PK/PD, and biomarker data into dosing and clinical decisions.
- Provide medical oversight for ongoing trials (patient safety, data integrity, execution quality).
- Partner with Clinical Operations on enrollment strategy, operational excellence, and issue resolution.
- Review emerging data, conduct benefit–risk assessments, and guide adaptive development.
- Contribute to safety governance and data monitoring.
- Lead global regulatory interactions (FDA/EMA/others) including End-of-Phase, Scientific Advice, and pre-NDA/MAA engagements.
- Oversee medical content for INDs/amendments/briefing books/IBs/CSRs and NDA/MAA submissions.
- Anticipate regulatory risks and incorporate evolving guidance.
- Collaborate cross-functionally with Translational Medicine, Nonclinical, CMC, Biometrics, Commercial, and HEOR; other duties as assigned.
Required Qualifications
- MD or MD/PhD; board certification in Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related field.
- 10+ years clinical development experience (drug development lifecycle) and 15+ years total relevant experience.
- Demonstrated success with health authority interactions.
- Proven ability to design clinical trials and make benefit-risk decisions with limited data.
- Effective communicator with leadership presence; can influence internal/external stakeholders.
Preferred Qualifications
- Experience in liver disease, MASH/NASH, metabolic disorders, cardiometabolic disease, inflammation, or endocrine pathways.
- Experience supporting/leading NDA/MAA submissions and/or outcomes studies.
- Experience advancing programs from early development through registration in a biotech setting.
Benefits
- Full-time employees receive base pay/bonus/equity and comprehensive benefits; full-time benefits include flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) (traditional, Roth, and employer match).
Application Instructions
- Applications accepted on an ongoing basis; submit through the Madrigal Careers site.