Johnson & Johnson Careers

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

Chiyoda, Japan
Clinical Trial Administration


Job Description

Requisition ID: 1805644920W

POSITION SUMMARY
  • 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 LINE
Report to Head of Japan Clinical Operation Division


PRINCIPAL RESPONSIBILITIES
  • 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


Qualifications
EDUCATION AND EXPERIENCE REQUIREMENTS
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
 


Primary Location
Japan-Tokyo-To-Chiyoda
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Clinical Trial Administration
Requisition ID
1805644920W