Caileen Cullen

WORK HISTORY

EDUCATION

ABOUT CAILEEN CULLEN

Experienced Clinical Trial Manager with 8+ years leading complex, end-to-end late-phase global Phase 3/OLE programs across oncology, rare disease, and women\'s health. Proven Clinical Operations Country Lead across North America, EU/UK, and Asia Pacific independently managing 70+ investigative sites, 11+ vendors, and cross-functional global teams within matrixed organizations. Deep expertise across the full study lifecycle from accelerated start-up through database lock and CSR population, with command of ICH/GCP, FDA, and EMA regulatory standards and a consistent record of inspection readiness. Known for institutionalizing operational best practices, driving global enrollment strategies, and serving as the foundational go-to leader for study processes, vendor governance, and cross-functional alignment uniquely positioned to deliver operational excellence for rare disease and oncology pipelines.