Global Clinical Program Lead
Core
Lead late-phase clinical development programs for respiratory and immunology indications, managing study design, execution, and global regulatory strategy to determine benefits and risks.
Role type
Senior Global Clinical Program Lead (Medical Director level)
Builds
Phase IIb, III, IV, and Life Cycle Management clinical studies
Domain
Biopharmaceuticals, Respiratory, Immunology, Autoimmune diseases
Required skills
Clinical study design, protocol development, trial implementation, safety surveillance, regulatory strategy, risk mitigation, line management, cross-functional collaboration
Preferred skills
Specialist training in allergy/immunology/autoimmune, experience with third-party collaborations, publication development
Technologies
GCP, pharmacovigilance, biostatistics, risk-based monitoring
Responsibilities
Supervise Global Development Medical Directors and Scientists; ensure clinical data supports label indications; represent program at health authority interactions; review Clinical Study Reports; manage study strategy for publications; deliver clinical information to regulatory agencies and investigators.
Seniority
Senior, hands-on IC with line management responsibilities