Director, Clinical Operations
Core
Lead end-to-end delivery of a Therapeutic Area portfolio in Japan by integrating Clinical Trial Management and Clinical Research Associate functions into a single operating model.
Role type
Senior Director, Clinical Operations (Therapeutic Area Lead)
Builds
Clinical trial programs (Phase I-IV) for serious diseases
Domain
Pharmaceutical industry, Clinical Research Operations
Required skills
Clinical trial operations leadership, managing managers (CTM and CRA), strategic portfolio planning, risk mitigation, GCP/ICH compliance, stakeholder partnership management, talent management, data analytics utilization
Preferred skills
AI tool application in clinical operations, field site visit experience, cross-functional matrix collaboration
Technologies
Digital platforms, data analytics tools, AI applications
Responsibilities
Own end-to-end accountability for clinical trial delivery and metrics (enrollment, quality, timeline, budget), align CTM and CRA line managers on resourcing and workload, make decisions on portfolio-level resource allocation and study prioritization, ensure GCP/ICH compliance and support Health Authority inspections, manage hiring and succession planning for line managers, collaborate with internal stakeholders and external partners including study sites and health authorities.
Seniority
Senior Director, strategic leadership with people management