CPL職(オンコロジー領域)/ノンラインマネージャーorスタッフ/医薬開発本部CDMAオンコロジー・免疫領域オンコロジー領域メディシン部
Basic purpose of the job*
Manage the timely approval of Nippon Boehringer Ingelheim products for target indications by providing appropriate and robust insights in Oncology area,
based on Japanese disease area- specific and healthcare environment, in collaboration with global (Early) Asset Team(s), (Early) Evidence Lead(s),
other departments of the Medicine Division, KPRI and Marketing
Accountabilities * |
Related performance indicators |
Responsible for making Japanese (early) clinical development plan authorized by Boehringer Ingelheim global (early) Asset Team(s) as well aligned with global development strategy in Oncology therapeutic area |
-Keep development timeline |
Ensure Japanese submission(s) and registration(s) in Oncology therapeutic area are appropriately handled and obtained |
-Writing clinical overview in CTD and supervise of module 2 as clinical scientific reviewer |
Ensure all the projects in Oncology therapeutic area are correctly managed in both in timeline and in quality |
-Confirm project level documents related with regulatory interaction |
Support Nippon Boehringer Ingelheim management team in making development/data building decision based on whole picture (all projects/trials in the respects of resource/budget) in Oncology therapeutic area |
Provide project overview to Nippon Boehringer Ingelheim management team |
Ensure Nippon Boehringer Ingelheim provides safety related important information with appropriate assessment to stakeholders in timely manner during its product life in pre-launch phase |
Assess Oncology compounds’ safety profile in collaboration with PV colleagues and external medical advisor(s) in Oncology therapeutic area |
Support Nippon Boehringer Ingelheim obtains preferable pricing in Japan |
Supports market access activities(pricing negotiation,proper use promotion etc.)where necessary. |
Knowledge transfer to MA/MSL groups and other relevant business function(s) |
Transfer knowledge and network through clinical development to MA/MSL groups and other relevant business function(s). |
Establish strong network with Japanese external experts supporting our product |
Build network with key Japanese external experts through clinical development in collaboration with MA/MSL/CD&O |
Regulatory and / or Organizational 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 preparation of local Integrated Asset Plan (IAP) & Integrated Customer Plan (ICP) to include Japan specific needs, together
ith 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
-Project management skills as a lead
-English communication skills beyond daily conversation
-Complete understandings of the current standard of care for specific cancer types