Associate Director Drug Product SME

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.

The Associate Director Drug Product SME is an experienced scientific leader, with responsibility for advancing the CMC development of Madrigal’s small molecule portfolio. This role focuses on drug product formulation and process development, ensuring preclinical and clinical studies are supported with phase appropriate quality investigational medicinal product, delivered on time and guided by scientific rigor, risk assessment and data-driven decision-making. The Associate Director is expected to lead at least one cross-functional CMC team, supporting the development of a clinical-stage asset.

As a key member of CMC development project teams within Technical Operations, this leader may also serve as a program-level CMC lead across preclinical development, clinical development, scale-up, registration, and commercialization.  This role executes drug product development deliverables by translating drug product strategy into protocols, data packages, and external partner deliverables. Responsibilities include leading hands-on technical evaluation of formulation and processing options, supporting drug product troubleshooting, and ensuring readiness and oversight for clinical supply manufacture.

The Associate Director will produce high-quality reports and documentation inputs that support CMC authoring, regulatory traceability, and program decision-making. This role requires strong internal partnership with Quality, Research, Regulatory Affairs, Drug Safety, Clinical, and Supply Chain teams, as well as effective oversight of external CDMO and CRO relationships supporting candidate development across all phases. Ultimately, the ideal candidate is a collaborative technical leader, with expertise in small molecule modalities, who can build and contribute to a high-performing Pharmaceutical Science team supporting the development of an industry-leading MASH-focused pipeline.
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* Key Responsibilities:

**** Drug Product Development and Technical Strategy
*** Lead or support the generation of comprehensive pre-formulation data packages and asset profiles to inform develop ability assessment, development strategy, and program planning.
* Lead or support phase-appropriate development, optimization, and delivery of small-molecule formulations, associated processes, and material supply from preclinical through clinical development.
* Provide expertise in formulation and process development strategies to address bioavailability risks and enable fixed-dose combination development with Rezdiffra (resmetirom), where applicable.
* Lead or support registration, final scale-up, process validation, and commercial presentation development in accordance with cGMP, ICH, FDA, and internal target product profile requirements.  
** External Partner and CDMO Oversight
*** Serve as or support the primary drug product contact for CDMOs and oversee key deliverables, including protocols, batch records, reports, investigations, and technical documentation.
* Troubleshoot drug product issues, develop root-cause hypotheses, and coordinate resolution with cross-functional internal and external partners.
* Support drug product technology transfer readiness, including process descriptions, control strategies, sampling plans, comparability considerations, and transfer documentation.
* Support leadership and Global Procurement in defining and maintaining a CDMO/CRO…