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

-Reflect Japan needs, plans and timeline in the CDP

-Continuously update Japanese development plan and issue with global Asset Team(s)

-Ensure adequacy of Japanese submission package and adequacy of trial design

-Integrate feedback from the aspect of “post launch” medical needs into Japanese clinical development plan in the therapeutic area

-Japanese version IB update

-Maximize external expert engagement in order to gather valuable information in Japanese clinical development where necessary

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 Japanese RMP (Risk Management Plan) document is sufficiently qualified as a part of J-CTD

-Responsible for the clinical part until approval, such as preparation of responses to PMDA queries

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

-PMDA consultation meeting materials and answers to PMDA inquiries

-Provide appropriate site recommendations to CD&O and promote patient recruitment

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).

Support medical affairs to build evidence in Asia and Japan

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

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.