Senior Director, Clinical Supply Release

Madrigal Pharmaceuticals seeks a Senior Director to oversee quality assurance disposition and release of clinical supplies for investigational MASH therapeutics. The role ensures compliant, traceable execution while coordinating across clinical operations, manufacturing, supply chain, and external vendors to meet trial timelines.

Responsibilities

• Own release criteria, checklists, and documentation standards for consistent, compliant disposition decisions
• Drive cycle-time improvements and produce release dashboards, checklists, and performance reports
• Coordinate deviations, investigations, and change controls impacting release timelines with risk-based assessment
• Maintain audit-ready release documentation and oversee external clinical vendors for compliance with labeling and packaging expectations
• Partner with Clinical Ops and Supply Chain on release schedules, priorities, and mitigation planning

Requirements

• Bachelor's degree or higher in science or engineering
• 15+ years of GMP quality assurance and release experience
• Clinical supply chain experience strongly preferred
• Strong documentation discipline and cross-functional coordination skills
• Ability to travel 20-30% domestically and internationally
• Veeva Vault Quality (eQMS) proficiency
• Experience supporting GxP inspections involving clinical supply activities

Compensation: $244,600 - $299,000 per year