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Johnson & Johnson キャリア

【Janssen】 R&D Japan Clinical Science Div., Hematology Clinical Lead (Manager)

千代田区, 日本
R&D


仕事内容

Requisition ID: 1905745038W

Janssen R&D Japan Clinical Science Div., Hematology Clinical Lead (Manager)

 
Purpose:  

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 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.

 
Major Responsibilities:

Compound life cycle management:

Executes R&D KOL management.

Execute 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, knowledge transfer to JCOL, and execute clinical study oversight of clinical studies, in addition to creating and updating the following documents:

- Investigator’s Brochure (IB)

- 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.

- Criteria of protocol deviation, 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, if any.

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.

Post marketing activities:

Contributes to package insert (J-labelling) development.

Supports to develop risk management plan including post marketing surveillance studies led by JSS.

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.

 


資格
Position Qualifications:

M.S. or equivalent is required (M.D., Ph.D. – preferable).

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.

 

Critical Leadership Imperatives:

Builds strong and positive relationships with R&D leaders and partners, colleagues and related functions.

Identifies unsolved needs per insights and find effective solutions thought-out cross function-wide collaborations.

Delivers add-value solutions from insights, and challenge against status-quo for positive change onto the organization.

Takes risk and manage it without jeopardizing quality and/or compliance. 

Responses talent development, talent fulfillment, and performance improvement, by having diverse visions, experiences, and ability.

Contributes high performance organization by transparent conversation.

Demonstrates leadership to act speedy, agility and accountability.

Acts to yourself to make local R&D-wide decision-making, which makes balance between short-term performance and long-term vision. 

 
 


プライマリ場所
日本-東京都-千代田区-
組織
Janssen Pharmaceutical K.K. (7195)
ジョブ
R&D
Requisition ID
1905745038W