Senior Director, Clinical Development (MD)

About the role

The Senior Director, Clinical Development is a senior physician leader responsible for providing strategic and operational leadership across Madrigal Pharmaceuticals’ clinical-stage pipeline, currently encompassing three programs and seventeen clinical studies spanning early through late-stage development.

Responsibilities

• Provide strategic clinical leadership within the three clinical-stage programs and seventeen active studies, ensuring alignment with corporate objectives and long-term value creation.
• Lead and oversee integrated Clinical Development Plans (CDPs) from early clinical development through registration and lifecycle management.
• Establish clear development milestones, go/no-go criteria, and risk mitigation strategies for the clinical stage program.
• Serve as the medical voice for assigned programs at governance forums and executive leadership meetings.
• Lead design and medical oversight of Phase I–III clinical trials, including FIH, PoC, registrational, and outcomes studies.
• Define clinical endpoints, biomarker strategies, patient populations, statistical assumptions, and differentiation strategies.
• Integrate translational, PK/PD, and biomarker data into dosing strategies and clinical decision-making.
• Ensure consistency, scientific rigor, and strategic coherence across multiple studies within each program.
• Provide medical oversight for ongoing clinical trials, ensuring patient safety, data integrity, and high-quality execution.
• Partner with Clinical Operations to ensure operational excellence, enrollment strategy optimization, and proactive issue resolution.
• Review emerging data, conduct benefit–risk assessments, and guide adaptive development strategies as needed.
• Contribute to safety governance and data monitoring activities.
• Serve as Clinical Development subject matter expert regulatory interactions globally (FDA, EMA, and other health authorities), including End-of-Phase meetings, Scientific Advice, and pre-NDA/MAA engagements.
• Oversee the medical content and strategic framing of INDs, amendments, briefing books, Investigator Brochures, CSRs, and NDA/MAA submissions.
• Anticipate and proactively address regulatory risks, incorporating evolving guidance into development strategy.
• Partner with Translational Medicine to refine biomarker strategies, patient stratification approaches, and mechanism-based differentiation.
• Collaborate with Nonclinical and CMC teams to support safety packages, manufacturing readiness, and lifecycle planning.
• Work with Commercial and HEOR teams to ensure TPP alignment, competitive positioning, and value demonstration strategy.

Qualifications

• MD or MD/PhD required; board certification in a relevant specialty (Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related field).
• 10+ years of clinical development experience across the drug development life cycle with 15+ years of total relevant experience.
• Demonstrated success in healthy authority interactions.
• Proven ability to design clinical trials and make benefit-risk decisions with limited data.
• Effective communicator with strong leadership presence and ability to influence internal and external stakeholders.

Preferred / Desired Qualifications

• Experience in liver disease, MASH/NASH, metabolic disorders, cardiometabolic disease, inflammation, or endocrine pathways.
• Experience supporting or leading NDA/MAA submissions and/or outcomes studies.
• Experience advancing programs from early development through registration in a biotech setting.