Senior Director, Clinical Supply Release

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $244.6k - $299k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Madrigal Pharmaceuticals

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $259M Post-IPO Equity on 2022-12

Healthcare • Pharmaceuticals • Biotechnology

Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). The company achieved a significant milestone with the accelerated FDA approval of its first therapy for adults with NASH with moderate to advanced liver fibrosis. Madrigal is actively conducting a Phase 3 trial for the treatment of NASH with compensated cirrhosis. The company is dedicated to improving care for patients with NASH/MASH through its ambitious research programs and therapeutic developments.

📋 Description

• Own QA disposition and release of clinical supplies to support trial timelines while ensuring compliant, traceable execution • Ensure batch and packaging record completeness, labelling readiness, and release criteria execution for investigational products and clinical supply operations • Coordinate with Clinical Ops, CMC, Supply Chain, and external vendors to manage priorities and reduce release bottlenecks • Oversee deviations, investigations, and change controls impacting clinical release timelines with risk-based assessment and documentation rigor • Maintain inspection readiness through audit-ready clinical supply release documentation and governance • Own release criteria, checklists, and documentation standards and drive consistent, compliant disposition decisions • Drive cycle-time and right-first-time improvements for clinical release workflows • Produce release checklists, release dashboards, and clinical release cycle-time reports • Ensure QA oversight over clinical packaging runs • Coordinate deviations, investigations, and change controls, ensuring timely risk assessments and action closure • Partner with Clinical Ops and Supply Chain on release schedules, priorities, and mitigation plans • Produce release risk summaries, issue/action logs, and escalation briefs • Maintain audit-ready release documentation and evidence packages and support GxP inspections • Oversee external clinical vendors as applicable and ensure compliance with labelling and packaging expectations • Produce inspection-ready evidence indexes and vendor oversight packs

🎯 Requirements

• BS+ in Science, Engineering, or related field • 15+ years of GMP QA/release experience, with clinical supply experience strongly relevant • Strong documentation discipline • Strong cross-functional coordination capability • Ability to travel 20–30% domestically and internationally • Experience in pharmaceutical or biotech clinical supply chains preferred • Experience with IMP labelling/packaging preferred • Experience with external clinical vendors preferred • Experience supporting GxP inspections involving clinical supply release activities • Proficiency with Veeva Vault Quality (eQMS) to manage clinical release documentation and quality events impacting timelines • Knowledge of clinical supply release governance, batch/packaging record review, and disposition decision-making • Knowledge of cycle-time management, labelling/packaging readiness, controlled documentation, and inspection-readiness evidence quality • Experience coordinating deviations, investigations, and change controls for clinical timelines • Ability to perform risk-based escalation and action closure • Partner governance and performance management across external clinical vendors • Cross-functional leadership, escalation, and executive-ready risk/decision communication

🏖️ Benefits

• Equity for all employees • Flexible paid time off • Medical insurance • Dental insurance • Vision insurance • Life/disability insurance • 401(k) traditional, Roth, and employer match offerings • Supplemental life insurance • Legal services • Mental health benefits through the Employee Assistance Program for employees and their family • Reasonable accommodations throughout the hiring process