Senior Director, Clinical Supply Release

Location: Conshohocken

## Senior Director, Clinical Supply Release Apply locations:
PA
- Conshohocken
- Office time type:
Full time posted on:
Posted Yesterday job requisition :
is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH.

Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration.

To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

Owns QA disposition and release of clinical supplies to support trial timelines while ensuring compliant, traceable execution. Ensures batch / packaging record completeness, labelling readiness, and release criteria execution for investigational products and clinical supply operations. Coordinates closely with Clinical Ops, CMC, Supply Chain, and external vendors to manage priorities and reduce release bottlenecks. Oversees deviations, investigations, and change controls impacting clinical release timelines with risk-based assessment and documentation rigor.

Maintains inspection readiness through audit-ready clinical supply release documentation and governance.
** Key Responsibilities
**** Disposition / Release Execution
*** Own release criteria, checklists, and documentation standards, ensure consistent, compliant disposition decisions
* Drive cycle-time and right-first-time improvements for clinical release workflows
* Produce deliverables such as release checklists, release dashboards, and clinical release cycle-time reports
* Ensure QA oversight over clinical packaging runs
** Issue Management & Cross-Functional Coordination
*** Coordinate deviations / investigations / change controls impacting release timelines, ensure timely risk assessments and action closure
* Partner with Clinical Ops / Supply Chain on release schedules, priorities, and mitigation plans
* Produce deliverables such as release risk summaries, issue / action logs, and escalation briefs
** Inspection Readiness & Vendor Oversight (as applicable)
*** Maintain audit-ready release documentation and evidence packages, support GxP inspections
* Oversee external clinical vendors as applicable and ensure compliance with labelling / packaging expectations
* Produce deliverables such as inspection-ready evidence indexes and vendor oversight packs
** Required Qualifications
*** BS+ Science / Engineering (or related)
* 15+ years GMP QA / release experience (clinical supply experience strongly relevant)
* Strong documentation discipline and cross-functional coordination capability
* Ability to travel 20-30%, both domestic and international
** Preferred Qualifications
*** Experience in pharmaceutical / biotech clinical supply chains, IMP labelling / packaging, and external clinical vendors (preferred)
* Experience supporting GxP inspections involving clinical supply release activities
** Key Competencies
*** Clinical supply release governance, batch / packaging record review, and disposition decision-making,…