Executive Director, Pharmaceutical Science

Executive Director, Pharmaceutical Science

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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.

Position Opportunity

The Executive Director of Pharmaceutical Science is a senior leadership role dedicated to supporting the CMC development of drug candidate molecules of any modality, primarily small molecule, from preclinical development through process validation and regulatory approval. The Executive Director of Pharmaceutical Science will serve as a key member of the CMC executive leadership team, responsible for building and leading the company’s CMC strategy across pre-clinical and clinical development, scale-up, and commercialization.

The role requires a highly collaborative individual that establishes excellent relationships/partnerships with Quality, Research, Regulatory Affairs, Drug Safety, Clinical, Supply Chain, external partners, etc. The role requires the strategic oversight of all Pharmaceutical Sciences activities at Madrigal, with a primary emphasis on Drug Product Formulations that insure that all drug safety studies and clinical trials are supported with appropriate quality IMP in a timely manner.

This role will establish and oversee all externalized laboratory activities, including API form evaluation and selection, formulations to support drug discovery and pre-clinical activities and formulation design and development for clinical studies and ultimately commercial sale. The Executive Director of Pharmaceutical Science is accountable for the invention, development and validation of high quality API final forms, formulations and processes that are developed with a risk mindset consistent with regulatory and ICH guidance.

The Executive Director of Pharmaceutical Science is expected to lead at least one cross functional CMC team responsible for the development of a Clinical Development Asset. The ideal candidate will be highly collaborative and build a high performing Pharmaceutical Science team that supports the development of an industry leading NASH/MASH focused pipeline.

This position reports into the Vice President of CMC.

• Strategic oversight for all drug product teams and their activities from API Final Form selection, development of preclinical formulations, definition and development of fit for purpose formulations to support early clinical development through definition of robust commercial formulations that meet the Target Patient Profile.
• Oversee all aspects of the lifecycle of formulation development including drug product definition, process development and characterization, DOE and robustness studies through to partnering with MS&T for successful process validation
• Partner with the Executive Director of Organic Chemistry in the generation, evaluation, selection and development of final API forms.
• Provide strategic guidance to enable empowered CMC and Pharmaceutical Science teams to define stage appropriate processes and control…