Executive Director, Analytical Chemistry Lead
About The Position
Madrigal is seeking an Executive Director, Analytical Chemistry Lead to own analytical development strategy and execution oversight. The role ensures fit-for-purpose methods and characterization packages support drug substance and drug product decisions, release readiness, and stability programs. The lead establishes method lifecycle expectations, data integrity standards, and external laboratory governance to maintain reliable, traceable data. The role partners with drug substance, drug product, and CMC Strategy teams to align specifications, reference standards, and analytical rationales within a phase-appropriate control strategy.
Requirements
- Bachelor’s degree or higher in Analytical Chemistry or a related field.
- 18 or more years of analytical development experience in a regulated environment.
- Demonstrated leadership of method strategy, data integrity, and external partner oversight.
- Strong cross-functional communication and documentation skills.
Nice To Haves
- Advanced degree.
- Experience supporting solid-state characterization strategies and polymorph programs.
- Experience supporting pharmaceutical regulatory filings and health authority responses.
Responsibilities
- Define analytical strategy and prioritization across assets, including release, stability, and in-process work.
- Ensure method development and qualification plans meet program timelines and decision needs.
- Govern external analytical execution, data review standards, and issue escalation.
- Align specifications, reference standards, and analytical justifications with drug substance and drug product strategy.
- Ensure analytical sections and rationales are ready for CMC authoring and regulatory filings.
Benefits
- Equity for all employees.
- Flexible paid time off.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- Life and disability insurance.
- 401(k) offerings, including traditional and Roth options and employer match.
- Supplemental life insurance.
- Legal services.
- Mental health benefits through the Employee Assistance Program for employees and their family.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Executive
