1. Objectives
Responsible for clinical development of the assigned project in Japan under the supervision of the Japan Development Leader (JDL), who assumes responsibility for development of all projects in Japan in the respective therapeutic/disease area (TA/DA). Exercises proactive leadership in the project and obtains approval in Japan. Works with the Global Clinical Leader (GCL) and Clinicians to formulate and execute the global and Japan development strategies of the project.
2. Roles and Responsibilities
- Evaluate candidates for development in the assigned TA/DA from scientific and technical aspects and formulate an effective development plan for Japan with the JDL and the global team. Contribute to establishing the global development plan by discussing points to consider in developing the product (including biomarkers and diagnostics) and obtaining approval in Japan (e.g. medical practice, communication with the government) with the global team and considering strategies towards early launch.
- Establish good working relationships with internal and external stakeholders [e.g. key opinion leaders (KOL), academic society, patient group] to enhance the possibility of expedited development and early approval with the JDL and senior JCL.
- Lead Japan Development Team (JDT) and clinical studies of assigned project to success in cooperation with JDT and global team members.
- Communicate closely with the GCL and Clinicians in Worldwide Research and Development (WRD) and respective Business Units (BU) and build and execute an effective development strategy.
- Prepare high quality documents (e.g.study outline, briefing document, CTD, query response, publications) and review them.
- When a Clinical Scientist (CS) is assigned to the project, review the documents prepared by the CS (e.g. full protocol, informed consent document, investigator's brochure); when a CS is not assigned, the JCL is responsible to prepare and review these documents.
- Contribute to the preparation of the risk management plan for J-NDA submission and other documents required after approval.
- Review clinical data and protocol deviations and determine necessary actions for clinical studies in which he/she is the Clinical Lead. Review individual subject and cumulative safety data based on the safety review plan.
- Lead preparation of procedures related to independent data monitoring committee (IDMC), adjudication committee (AC), and safety review committee, and manage and execute the committees.
- Continuously seek opportunities for improvement in daily work and propose and implement actions without being ruled by conventional work habits.
3. Skills and Behavior Requirements
Training & Education Preferred:
- Scientific background in education, >3 years or more experience in clinical development