Director, Global Clinical Program Lead
Core
Design and execute clinical strategy and oversee clinical development programs for biotherapeutics in immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas.
Role type
Senior clinical program lead (medical monitor)
Builds
Clinical Development Plans, study protocols, regulatory packages, and clinical study reports
Domain
Life sciences / Clinical development / Biotherapeutics
Required skills
Clinical development strategy, medical monitoring, regulatory compliance (GCP/ICH), cross-functional leadership, scientific writing, data analysis, stakeholder management
Preferred skills
Board certification in relevant field, extensive pharmaceutical industry experience
Technologies
Clinical Development Plan (CDP), Project Strategy Document (PSD), Investigator Brochure (IB), Clinical Study Protocol (CSP), Medical Monitoring Plan (MMP), Clinical Study Report (CSR)
Responsibilities
Lead the Clinical Development Team, ensure alignment with GCP/ICH regulations, serve as medical monitor or oversee monitors, author key study documents and regulatory sections, present results to safety committees
Seniority
Senior, hands-on IC