Vice President, Clinical Development Program Leader

Madrigal Pharmaceuticals seeks a Vice President to lead clinical development strategy and execution across therapeutic programs focused on MASH treatment. The role combines early-stage asset guidance through IND submission with late-stage program oversight, regulatory interactions, and cross-functional team leadership.

Responsibilities

• Lead cross-functional program teams and develop integrated clinical development strategies and plans
• Oversee clinical trial design and medical oversight from first-in-human through Phase IV studies
• Manage regulatory interactions with FDA, EMA, PMDA, and other global agencies; prepare and defend submissions
• Integrate clinical development, biostatistics, CMC, regulatory, and safety functions across assigned programs
• Mentor clinical scientists and establish early-development frameworks, processes, and scalable best practices

Requirements

• MD or DO with board certification in Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related specialty
• 10–15+ years clinical development leadership experience across early and late-stage programs
• 20+ years total relevant experience in drug development and clinical strategy
• Proven success leading programs through regulatory filings (INDs, NDAs, BLAs) and commercialization
• Strong translational medicine, biomarker, and PK/PD background
• Demonstrated experience managing pre-IND and IND interactions with global regulatory agencies
• Ability to lead cross-functional matrixed teams and influence without direct reporting authority