Company
[R&D]JapanClinicalLeader
“[R&D] Japan Clinical Leader. Skills: Clinical development strategy, Clinical study leadership, Stakeholder management, Cross-functional collaboration, Regulatory submissions understanding. Responsible for clinical development of the assigned project in Japan. Exercises proactive leadership in the project and obtains approval in Japan”
What You'll Achieve.
Obtains approval in Japan; Possibility of expedited development and early approval; Lead Japan Development Team (JDT) and clinical studies of assigned project to success; Build and execute an effective development strategy; Contribute to the preparation of the risk management plan for J-NDA submission and other documents required after approval
Industry & Context.
Problem solving skills; Skill to think logically; Determine necessary actions for clinical studies
What They're Looking For.
Must Have
Scientific background in education, >3 years or more experience in clinical development, Experience in clinical thorough understanding of the processes associated with clinical and regulatory submissions, Skill to design and execute development strategies (e.g. advanced medical and pharmaceutical knowledge, skill to design development strategies, knowledge on clinical study operations including guidelines and SOPs, skill to think logically, innovatively, and flexibly, writing skills), Leadership skills, Team building skills, networking skills, Negotiation skills, consensus building skills, Problem solving skills, Project management skills, Excellent writing and communication skills in both Japanese and English, Presentation skills, logical and scientific expertise to discuss with internal/external and Japanese/global stakeholders, Sustained delivery and innovation within the discipline, Sustained contribution to the pharmaceutical R&D process at the study level, Proven ability to contribute to multiple projects, Successful management of medium-sized teams consisted by multiple functions
What You'll Do.
Responsible for clinical development of the assigned project in Japan
Exercises proactive leadership in the project and obtains approval in Japan
Formulate and execute global and Japan development strategies
Evaluate candidates for development from scientific and technical aspects
Formulate an effective development plan for Japan
Contribute to establishing the global development plan
Discuss points to consider in developing the product (including biomarkers and diagnostics)
Consider strategies towards early launch
Lead Japan Development Team (JDT) and clinical studies
Prepare high quality documents
Review documents prepared by Clinical Scientist (CS)
Prepare and review documents if CS is not assigned
Contribute to the preparation of the risk management plan for J-NDA submission
Review clinical data and protocol deviations
Determine necessary actions for clinical studies
Review individual subject and cumulative safety data
Lead preparation of procedures related to IDMC
and safety review committee
Manage and execute committees
Continuously seek opportunities for improvement in daily work
Propose and implement actions without being ruled by conventional work habits
How You'll Work.
Team & Collaboration
Works with the Global Clinical Leader (GCL) and Clinicians to formulate and execute strategies; Establish good working relationships with internal and external stakeholders [e.g. key opinion leaders (KOL), academic society, patient group]; Cooperate with JDT and global team members; Communicate closely with the GCL and Clinicians in Worldwide Research and Development (WRD) and respective Business Units (BU); Discuss with internal/external and Japanese/global stakeholders
Communication Scope
Excellent writing and communication skills in both Japanese and English; Presentation skills; Logical and scientific expertise to discuss with internal/external and Japanese/global stakeholders
Process & Methodology
Project management skills, Manage and execute committees (IDMC, AC, safety review)
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