Senior Director, Clinical Supply Release

Madrigal Pharmaceuticals; Conshohocken (Montgomery County); On-site; USD 245,000 - 299,000; Full time

Benefits offered by this job

Equity opportunities

Job summary

At Madrigal Pharmaceuticals, we seek an experienced QA professional to own disposition and release of clinical supplies, ensuring compliant, audit-ready workflows and documentation. You will collaborate with Clinical Ops, CMC, Supply Chain, and vendors to prevent release bottlenecks and maintain inspection readiness.

The role requires 15+ years of GMP QA/release experience, strong documentation discipline, and travel up to 30% domestically and internationally.

Qualifications

• BS in science or engineering or related field.
• 15+ years GMP QA / release experience (clinical supply strongly relevant).
• Strong documentation discipline and cross-functional coordination.
• Willingness to travel 20–30% domestically and internationally.

Responsibilities

• Own release criteria, checklists, and documentation standards, ensuring consistent, compliant disposition decisions.
• Drive cycle-time and right-first-time improvements for clinical release workflows.
• Produce deliverables such as release checklists, dashboards, and clinical release cycle-time reports.
• Ensure QA oversight over clinical packaging runs and vendor oversight (as applicable).
• Coordinate deviations / investigations / change controls impacting release timelines, with risk-based assessments.

Skills

Documentation discipline

Cross-functional coordination

Travel readiness

Education

BS in Science / Engineering

Job description

Madrigal 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, cycle-time management
• Labelling / packaging readiness interface and controlled documentation discipline, inspection readiness evidence quality
• Deviation / investigation / change control coordination for clinical timelines, risk-based escalation, and action closure
• Partner governance and performance management across external clinical vendors (as applicable)
• Cross-functional leadership, escalation, and executive-ready risk / decision communication
• Veeva Vault Quality (eQMS) proficiency to manage clinical release documentation and quality events impacting timelines

Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $244,600 - $299,000 per year. We comply with all applicable minimum wage laws.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [e-mail].

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to [e-mail].