Japan Clinical Lead (JCL) is accountable for all scientific discussion/deliverables, especially study design and outlines, study results and clinical data package in clinical studies in the assigned compound(s), from early to post-marketing, that Japan Compound Team (JCoT) is responsible.
JCL is responsible to execute designing, implementation and completion of clinical studies fulfilling clinical data package for appropriate New Drug Application (J-NDA) submission and is also responsible to execute appropriate communication with PMDA with regard to clinical studies;
e.g. PMDA consultation, J-NDA submission, etc.
Compound life cycle management:
Executes R&D Key Opnion Leaders management.
Executes R&D publications based on the agreed R&D publication plan.
Development planning and execution:
>Creates, revises and maintains study design and outlines, scientific rationale, Protocol Element Document (PED) and full protocol of the clinical studies aligned with the clinical study plan.
Provides leadership to implement study protocol including knowledge transfer to Japan Clinical Operation Leader (JCOL), execution of clinical study oversight of clinical studies in Japan, and also to prepare for the following documents:
EDUCATION, EXPERIENCE & SKILL REQUIREMENTS:
・M.S. or equivalent is required (M.D., Ph.D. ‐ preferable).
・Preferable to have 10 or more years of clinical development experience including 2 or more years as Clinical Scientist planning and executing clinical trails with experience of registration in Japan. Experience in oncology especially in Hematology is preferred, but strong experience in other therapeutic areas are also considered.
・Strong oral and written communication skills in both English and Japanese.
・Good planning and tracking skills.
・Demonstrates influence, negotiation and conflict resolution skills, including the ability to influence without clear reporting authority.
・Good problem solving skills for developing creative solutions.
・Critical Leadership Skills
・Cultivate external relationships and partnerships
・Builds strong and positive relationships with R&D leaders and partners, colleagues and related functions.
・Challenge the status quo; lead and adapt to change
・Takes risk and manage it without jeopardizing quality and/or compliance.
・Demonstrates leadership to act with speed, agility and accountability.