Senior Manager (m/w/d)
Core
Leading clinical development strategies for complex generic and Value-Added Generic drug programs, managing study planning and regulatory interactions.
Role type
Senior Manager, Clinical Development
Builds
Clinical development programs for EU and US markets
Domain
Pharmaceuticals, Generics, Clinical Development
Required skills
Clinical development strategy, Clinical trial planning and management, CRO management, Regulatory document preparation, CTD module creation, Cross-functional team leadership
Preferred skills
Experience with bioequivalence or patient studies, International team collaboration
Technologies
CTD, Regulatory documents
Responsibilities
Develop clinical strategies for pharmaceutical development programs, Plan and steer clinical studies, Select and manage external study partners like CROs, Prepare scientific documents for regulatory interactions, Create and review clinical documents for submission dossiers, Collaborate with interdisciplinary project teams
Seniority
Senior, hands-on IC