Basic purpose of the job
In collaboration with the global early asset teams, the early evidence leads, other stakeholders in Medicine Division, KPRI, and the pipeline marketing teams, we will provide appropriate and robust insights into the oncology areas based on the Japan-specific medical environment, and achieve timely and accelerated approval of NBI assets for target indications.
Accountabilities
・Responsible for making Japanese early clinical development plan authorized by BI global early Asset Teams as well aligned with global development strategy in Oncology therapeutic area
・Ensure Japanese submissions and registrations in Oncology therapeutic area are appropriately handled and obtained
・Ensure all the projects in Oncology therapeutic area are correctly managed in both in timeline and in quality
・Support NBI management team in making development and/or data building decision based on whole picture in Oncology therapeutic area
・Ensure NBI provides safety related important information with appropriate assessment to stakeholders in timely manner during its product life in pre-launch phase
・Support NBI obtains preferable pricing in Japan
・Knowledge transfer to MA/MSL groups and other relevant business functions
・Establish strong network with Japanese external experts supporting our product
Regulatory and / or Organisational Requirements
-Ensure all the projects are correctly managed in timeline and quality
-Contribute to Strategy and Activity Review Committee meetings
-Ensure benefit/risk evaluations of products, ethics and compliance
-Ensure all the projects are correctly managed in timeline and quality
-Contribute to Strategy and Activity Review Committee meetings
-Ensure benefit/risk evaluations of products, ethics and compliance
-Ensure preparation of local Integrated Asset Plan (IAP) & Integrated Customer Plan (ICP) to include Japan specific needs, together with Asset Team colleagues & aligned with global IAP
Job Complexity
Work as a project lead in Japan (Early) Evidence Team and especially closely collaborate with global (Early) Asset Lead(s) and (Early) Evidence Lead(s)
Interfaces
Global Asset Team(s), Japan Asset Team colleagues, PV team, Therapeutic Area Leadership Team, Team Member Global Epidemiology
Job Expertise
Full understandings of regulatory and compliance requirement in clinical development
Minimum Education/Degree Requirements
Bachelor of Science
Required Capabilities (Skills, Experience, Competencies)
The following are mandatory:
-Experience in "Oncology" clinical or research setting with or without own publications, 3+ years industry experience as CPL
-Experience in PMDA consultation, the query response, and obtaining regulatory approval for the development compounds in charge
-Ability to make your own proposals for modifying project plans to meet the actual situation in Japan or to enable accelerated approval, based on a global development strategy
-Project management skills as a lead
-English communication skills beyond daily conversation
-Complete understandings of the current standard of care for specific cancer types
Recruiter : Tomatsu
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