Global Clinical Program Lead, Immunology
Core
Lead late-stage clinical development for small molecules, biologics, and cell therapy in gastroenterology and clinical immunology to support regulatory approval.
Role type
Senior IC Global Clinical Program Lead (Late Stage)
Builds
Phase IIb, III, IV, and Life Cycle Management clinical studies
Domain
Pharma / Clinical Immunology / Gastroenterology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical degree (MD/MD-PhD), specialist training in gastroenterology or clinical immunology, leading Phase 2-4 clinical trials, biostatistics knowledge, global regulatory environment expertise, pharmacovigilance experience, clinical study design, protocol writing, medical monitoring, safety surveillance, regulatory agency communication, line management of study physicians and scientists
Preferred skills
Experience in leading or reviewing clinical programs for indication design and Target Product Profile, cross-project collaboration, fast-learning curve in new disease areas
Technologies
Clinical Study Report, Statistical Analysis Plan, Case Report Forms, Risk-based Monitoring Plans
Responsibilities
Create overall clinical development plans and study designs; drive clinical and scientific decisions within Global Study Teams; ensure patient safety and compliance with Good Clinical Practice; provide scientific medical input to study documents; manage safety surveillance and adverse event reporting; review Clinical Study Reports; lead governance interactions (DRACs, DRCs, PRCs); co-lead publication strategy; manage line of project study physicians and scientists
Seniority
Senior, hands-on IC with line management responsibilities
