Director, Drug Product SME

Madrigal Pharmaceuticals seeks an experienced Director of Drug Product CMC leadership to advance formulation and process development for siRNA/oligonucleotide and small-molecule candidates across preclinical through commercial stages. The role combines hands-on technical strategy with cross-functional oversight of internal teams and external CDMO partners, supporting the company's MASH-focused pipeline.

Responsibilities

• Lead drug product development strategy and technical delivery across preclinical through commercial phases
• Oversee formulation optimization, process validation, and clinical supply readiness for portfolio candidates
• Serve as primary technical contact for CDMOs; troubleshoot issues and coordinate cross-functional resolution
• Author and review CMC technical reports, regulatory documents, and eCTD submissions
• Partner with Quality, Regulatory, Clinical, and Supply Chain to ensure alignment and inspection readiness

Requirements

• Extensive experience in drug product formulation development for siRNA/oligonucleotide modalities
• Demonstrated expertise in CMC strategy, process development, and scale-up activities
• Strong knowledge of Quality-by-Design, Quality Risk Management, and regulatory requirements (ICH, FDA, cGMP)
• Track record leading cross-functional teams and managing external CDMO/CRO relationships
• Experience authoring CMC documentation, regulatory submissions, and technical reports
• Scientific rigor in data-driven decision-making and design-of-experiment methodologies