Executive Director, Analytical Chemistry Lead
Listed on 2026-10-30
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Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Science/ Research
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 analytical development strategy and execution oversight to ensure fit-for-purpose methods and characterization packages support DS/DP decisions, release readiness, and stability programs. Establishes method lifecycle expectations, data integrity standards, and external lab governance to maintain reliable, traceable data.
Partners with DS/DP and CMC Strategy to align specifications, reference standards, and analytical rationales within a phase-appropriate control strategy.
- Define analytical strategy and prioritization across assets (release, stability, in-process).
- Ensure method development/qualification plans meet program timelines and decisions.
- Govern external analytical execution, data review standards, and issue escalation.
- Align specs, reference standards, and analytical justifications with DS/DP strategy.
- Ensure analytical sections and rationales are ready for CMC authoring and filings.
- BS+ in Analytical Chemistry or related (advanced degree preferred)
- 18+ years analytical development experience in regulated environment
- Demonstrated leadership of method strategy, data integrity, and external partner oversight
- Strong cross-functional communication and documentation skills
- Experience supporting solid-state characterization strategies and polymorph programs
- Experience supporting pharmaceutical regulatory filings and HA responses
- Analytical method lifecycle management and scientific rigor
- Data integrity mindset and investigation/troubleshooting leadership
- Spec/control strategy alignment and documentation clarity
- Vendor governance and cross-functional influence
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 $276,205 - $328,644 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…
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