Global Clinical Program Lead
Core
Lead late-phase clinical programs for respiratory and immunology indications, managing study design, execution, and global regulatory strategy to determine benefits and risks of compounds.
Role type
Senior Global Clinical Program Lead (Respiratory/Immunology)
Builds
Phase IIb, III, IV, and Life Cycle Management clinical studies for respiratory and immunology assets
Domain
Biopharmaceuticals / Clinical Development / Respiratory & Immunology
Required skills
Clinical study design, protocol development, global regulatory strategy, risk mitigation, safety surveillance, scientific medical input, stakeholder engagement, line management
Preferred skills
Experience with third-party collaborations, publication development, health authority interactions
Technologies
GCP, pharmacovigilance, biostatistics, regulatory submissions
Responsibilities
Supervise Global Development Medical Directors and Scientists; ensure clinical data supports label indications; facilitate cost/time/quality balance; represent program at health authority interactions; review Clinical Study Reports; manage adverse event reporting; lead study strategy for publications; provide scientific input to study documents
Seniority
Senior, hands-on IC with team leadership