Senior Clinical Research Director
Core
Lead the registrational development program and global regulatory submissions for Qfitlia® (fitusiran), a first-in-class antithrombin-lowering therapy for hemophilia.
Role type
Senior Clinical Research Director (Medical Lead)
Builds
Clinical development plans, regulatory submission dossiers, and global study execution for hemophilia treatments.
Domain
Biopharma / Hematology / Rare Diseases
Required skills
Clinical development strategy, regulatory affairs, medical reference, scientific data evaluation, cross-functional leadership, compliance with regulations
Preferred skills
MD/PhD degree, specialist training in Hematology/Internal Medicine/Pediatrics
Technologies
Clinical trial management systems, regulatory submission platforms
Responsibilities
Develop and implement clinical development plan strategies, lead execution of clinical development and study activities, contribute to clinical parts of submission dossiers, serve as medical reference ensuring data relevance, lead scientific data evaluation and dissemination, ensure strict compliance with regulations and company policies, foster a collaborative team environment
Seniority
Senior, hands-on IC with leadership responsibilities
