Associate Director Drug Product SME

Madrigal Pharmaceuticals•Conshohocken, PA

1d•$174,134 - $199,621

About The Position

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.

Requirements

PhD degree in Pharmaceutics, Chemistry or Material Sciences, or BS/MS degree and commensurate Pharmaceutical Science development and leadership experience
Minimum of 10 years of experience in Pharmaceutical Science and CMC leadership within the biopharmaceutical industry, with a strong background in CMC and Drug Product development.
Proven experience in small molecule drug product formulation/process development.
Proven experience working with CDMO/CRO’s in a fully outsourced paradigm, providing technical leadership and oversight for development & clinical supply manufacture, and driving technical solutions in an external environment.
Working knowledge of statistical design of experimental approaches, execution and analysis, development of CMC risk assessments & control strategies.
Knowledge of cGMP & ICH guidelines, global regulatory requirements & regulatory document authoring
Strategic and operational leader with a balance of scientific depth and business acumen
Strong Leadership skills with an ability to both influence and empower
Excellent problem-solving and risk management skills to address complex issues
Strong written and verbal communication and interpersonal skills with the ability to collaborate across functions, with external partners, and present to stakeholders
Detail-oriented with a focus on maintaining high standards of quality and compliance
Meticulous in review of documentation to ensure regulatory and quality robustness
Proactive and strategic thinker with an empowering approach to solving technical challenges
Aptitude for identifying inefficiencies, driving process improvements
Ability to mentor others

Nice To Haves

On-boarding and accelerating the mobilizing of new assets post-acquisition is desirable.
Demonstrated success in transitioning programs from clinical development to commercial manufacturing is desirable, including process validation and regulatory approval, in a cross-functional matrixed organization.
Regulatory agency interactions desirable

Responsibilities

Lead or support the generation of comprehensive pre-formulation data packages and asset profiles to inform developability 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.
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 network that meets current and future CMC business, regulatory, and quality needs.
Implement Quality-by-Design and Quality Risk Management principles throughout the development lifecycle, ensuring clear decision logs, assumptions, data traceability, and alignment with Quality, Regulatory, and Supply Chain standards. Ensure adherence to sound decision-making processes established through strong scientific rigor and robust data, leveraging cross-functional expertise.
Use statistical design-of-experiment practices and AI-enabled tools to increase efficiency and effectiveness in generating CMC knowledge and phase-appropriate control strategies.
May author, compile, and/or review drug product technical reports, regulatory source data, CMC regulatory documents, and quality documentation as required.
Review quality agreements, participate in audit programs, maintain inspection readiness, and represent the company as a CMC subject matter expert in regulatory inspections and audits as required.
Partner across Technical Operations, MSAT, Quality, Research, Regulatory Affairs, Drug Safety, Clinical, Supply Chain, and other stakeholders to ensure alignment across all stages of development.
Promote or support early development collaboration with MSAT to support future product robustness, supply resilience, and cost efficiency.
Support creation, submission, and tracking of fiscally responsible project budgets aligned with phase-appropriate and risk-tolerant project goals.
Champion a Right-First-Time culture focused on data integrity, scientific rigor, continuous improvement, and operational excellence across CMC and Technical Operations.