Johnson & Johnson キャリア

【Janssen】JAPAN, Head Clinical Trial Lead (Director)

千代田区, 東京都
Clinical Trial Administration


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

1. Education
  • Bachelor’s degree or an equivalent educational qualification is required; an advanced degree is preferred.
2. Experience/Knowledge
  • 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.
3. Skills Required
  • 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
Requisition ID