Johnson & Johnson キャリア
【Janssen】JAPAN, Head Clinical Trial Lead (Director)
Requisition ID: 1805644920W
- Direct, drive and manages the activities of Trial Lead department (TLD) to successful completion of clinical trials led by Japan Clinical Operation Leaders (JCOLs).
- Responsible for ensuring that all activities in TL department will comply with currently approved protocols/amendments, and with GCP, SOP, and all applicable regulatory requirements.
- Works with other JCO Line Managers and the Head of JCO to support and supervise all clinical trials in Japan.
Report to Head of Japan Clinical Operation Division
- Oversees clinical research strategies and contributes to the development and execution of clinical research programs by leading Japan Program Leaders (J-CPLs) and JCOLs.
- Supervises and monitors the activities of J-CPLs/JCOLs, implementation of clinical studies assigned to the department
- Ensures that all activities of J-CPLs/JCOLs are in compliance with department best practices, company policies and standardized procedures
- Responsible for the preparation of yearly budget and financial targets.
- Monitors, budgets and controls expenditure within established budgets.
- Ensures cross functional cooperation and coordination with clinical trials and establishes liaison with internal and external contributors
- Evaluate resources including HC periodically and solve the conflicts, if required
- Leads the objective setting, monitoring, coaching, and performance review of J-CPLs/JCOLs, with providing training and talent development approach
- Performs general and human resource administrative functions.
- Create and lead implement succession plan for own role and key talent in TLD
- Serves as a representative of the department to resolve cross functional issues and takes appropriate countermeasures
- Acquires and maintains understanding and expertise of clinical trials documentation, requirement, regulations, operational procedures, and policies
- Bachelor’s degree or an equivalent educational qualification is required; an advanced degree is preferred.
- Generally requires more than 10 years related experience.
- Knowledge / good understanding of pharmaceutical R&D processes, especially in clinical operations.
- Advanced knowledge of clinical research operations and systems.
- Previous resource allocation experience.
- Leadership experience.
- Experience of working in a global environment.
- Fluent in Japanese and English (written and spoken)
- At least master basic for Microsoft business applications
- Strong performance management and strategic thinking skill
Janssen Pharmaceutical K.K. (7195)
Clinical Trial Administration