Executive Director, Chemical Process R&D at Madrigal Pharmaceuticals in Conshohocken, PA

Job description

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. Owns DS process strategy and execution oversight, ensuring synthetic routes, RSM strategy, impurity understanding, and process controls enable scalable, safe, and cost-effective external manufacturing. Leads organic chemistry resources to generate process understanding, robust operating ranges, and tech transfer packages to CDMOs. Partners with Analytical Development and Engineering to align method readiness, process safety, and validation expectations, and ensures DS contributions to CMC documentation are clear and regulator ready. Key Responsibilities Process Strategy & Development Define DS route and RSM strategy aligned with phase-appropriate control strategy Approve process R&D plans (optimization, robustness, impurity investigations) Ensure DS deliverables support clinical supply builds and lifecycle readiness Tech Transfer & External Manufacturing Support Lead DS tech transfer expectations and readiness criteria for CDMOs Provide technical oversight for deviations, investigations, CAPA, and change impacts Drive continuous improvement initiatives (yield, cycle time, robustness) Cross-Functional Integration & Documentation Partner with Analytical on method needs for process characterization and control strategy Partner with Engineering on scale-up, safety, and equipment/process suitability Provide DS inputs and rationales for CMC documents and health authority responses Required Qualifications BS+ in Chemistry or related (PhD preferred) 18+ years process chemistry/DS development with external manufacturing support Demonstrated leadership of route development, impurity strategy, and tech transfer Strong technical writing and cross-functional leadership Preferred Qualifications Experience developing RSM strategies and supporting Phase 2 progression Experience supporting polymorph/solid-form implications for DS/DP interface Key Competencies Synthetic/process chemistry leadership and impurity/control strategy thinking Tech transfer and CDMO governance Risk assessment, troubleshooting, and decision framing High-quality CMC documentation inputs Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $276,205 - $328,644 per year. We comply with all applicabl