Executive Director, Analytical Chemistry Lead
Madrigal Pharmaceuticals
Summary
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.
Job description
Key Responsibilities
- 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
Required Qualifications
- 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
Preferred Qualifications
- Experience supporting solid-state characterization strategies and polymorph programs
- Experience supporting pharmaceutical regulatory filings and HA responses
Key Competencies
- 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
Requirements
- 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
Benefits
- Medical, Dental & Vision
- Life & Disability Insurance
- 401(k) Matching
- Equity
- Flexible PTO
- Mental Health Benefits
- Employee Assistance Program
- Supplemental Life Insurance
- Legal Services
Company overview
Madrigal Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), a serious form of fatty liver disease. The company's lead product, Rezdiffra (resmetirom), is a once-daily, oral thyroid hormone receptor (THR)-β selective agonist that targets key underlying causes of MASH in the liver. Rezdiffra received FDA approval in 2024 as the first treatment for MASH with moderate to advanced liver fibrosis, representing a significant breakthrough in hepatology. Headquartered in Conshohocken, Pennsylvania, Madrigal is publicly traded on NASDAQ under the symbol MDGL. The company continues to advance its clinical development programs, including ongoing Phase 3 trials evaluating Rezdiffra for the treatment of compensated MASH cirrhosis. Madrigal's innovative approach addresses a critical unmet medical need in liver disease therapeutics.