Director, Small Molecule Drug Product — Equity & Hybrid

Madrigal Pharmaceuticals Inc.; Conshohocken (Montgomery County); Hybrid; USD 204.000 - 250.000; Vollzeit

Benefits dieser Stelle

Equity

Comprehensive benefits

Flexible PTO

401(k) with employer match

Zusammenfassung

Madrigal Pharmaceuticals Inc. is seeking a Director Drug Product SME to lead the CMC drug product development strategy for our small molecule portfolio.

This role directs formulation and process development across preclinical to clinical stages, ensuring robust data packages and timely clinical supply readiness. The ideal candidate will drive cross-functional collaboration with Quality, Regulatory, and External partners, mentor a high-performing team, and shape strategy for scalable, compliant

Qualifikationen

• Minimum 12 years of Pharmaceutical Science and CMC development experience.
• Proven leadership in small molecule drug product formulation/processing.
• Experience leading CDMO/CRO programs in outsourced paradigm with external partners.
• Experience onboarding assets post-acquisition is desirable.
• Demonstrated statistical DOE strategy and risk assessment leadership.
• Strong knowledge of cGMP & ICH guidelines; regulatory document authoring experience.
• Ability to coach and develop technical talent.

Aufgaben

• Lead preclinical to clinical development of small-molecule formulations and processes.
• Ensure readiness for clinical supply manufacture and scale-up.
• Oversee CDMO/CRO relationships and vendor performance.
• Drive Quality-by-Design and risk management across lifecycle.
• Mentor and develop a high-performing CMC team.

Kenntnisse

Strategic leadership

Cross-functional leadership

CMC expertise

Data-driven decisions

Regulatory collaboration

Ausbildung

PhD in Pharmaceutics/Chemistry/Materials

Jobbeschreibung

Madrigal Pharmaceuticals Inc. is seeking a Director Drug Product SME to lead the CMC drug product development strategy for our small molecule portfolio.

This role directs formulation and process development across preclinical to clinical stages, ensuring robust data packages and timely clinical supply readiness. The ideal candidate will drive cross-functional collaboration with Quality, Regulatory, and External partners, mentor a high-performing team, and shape strategy for scalable, compliant