JCL (Japan Clinical Lead) 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 JCoT (Japan Compound Team) 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 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 JCOL, execution of clinical study oversight of clinical studies in Japan, and also to prepare for the following documents:
- Investigator’s Brochure (IB) – Japanese translated version.
- FAQ on patient eligibility or other medical issues and potential concerns during execution of clinical study in Japan.
- Summary of the compensation system for subject health injury in Japan.
- Major protocol deviation criteria, if any.
- Medical monitoring plan/medical review plan, if any.
- Statistical Analysis Plan (SAP)
- Analytical risk-based monitoring plan,
- Related other documents to clinical studies,
- Training materials for JCOL and study operation team involved.
・Provides leadership to execute medical monitoring while conducting independent clinical study in Japan (Local study).
Provides leadership to execute risk and feasibility assessment of full protocol of the studies including impact assessment of unapproved in Japan, out of scope in J-labelling, imported drugs regardless approval in Japan.
・ Provides leadership to create Clinical Study Report (CSR) of the Local study, relevant parts of
・Common Technical Document (J-CTD), including discussion on appropriate data interpretation from top line results and tabulations, and key message clarification.
・ Provides leadership to file CTD as JNDA including labeling discussion.
・ Executes own authority defined in the “authorization matrix” attached.
Post marketing activities:
・ Supports to develop risk management plan including post marketing surveillance studies led by
- If post marketing clinical study in Japan is considered, practical support will be necessary by JCL.
Reporting lines and talent pipelines:
・Provides feedback regarding Japan Clinical Scientists and Study Responsible Physician (in case of the Local study) to be reported to the Assoc. Dir.
Span of Control:
- Budget: not applicable.
- Headcount: not applicable.
- JCL is assigned every indication, done as Study Responsible Scientist (SRS) in the Local study.
5 years of pharmaceutical industry experience overall including clinical study experience at least three years. Preferable to demonstrate leadership in two or more development programs which led to successful clinical trial execution and registration in Japan
- 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
- M.S. or equivalent is required (M.D., Ph.D. – preferable)
Associate Director, Clinical Development Department- IDV TA, Clinical Science Division, Japan R&D, Janssen Japan.
Janssen Pharmaceutical K.K. (7195)
Clinical Research non-MD