CPL業務（70～80 %）+MA業務（20～30 ％)　時期により業務のふり幅に波がある **CPL (Clinical Program Lead):** **Basic purpose of the job** **：** Manage the timely development and HA (Health Authority) approval of NBI assets for target indications by providing appropriate and robust insights, based on Japanese TA (Therapeutic Area)-specific and healthcare environment, in collaboration with global & local Product’s Asset Team, Evidence Lead and respective Evidence and Value Network team members. **Accountabilities** **：** CDP/AEP： + Evaluate, propose, and execute the asset’s CDP (Clinical Development Plan). + Ensure the asset’s AEP (Asset Evidence Plan) integrated Japan needs (including but not limited to local medical/competitive landscape and differentiation) and in alignment with global asset strategy, agreed by Japan & Corporate Asset Team. J-NDA & Registration： + Support submission(s) and registration(s) of the assigned asset as a core Evidence Team member. + Author J-CTD clinical overview, supervise CTD module 2 as a scientific reviewer. + Lead the PMDA inquiries handling related to clinical part during J-NDA review period until approval is obtained. Market Access Support： + Support Market Access activities e.g., Ensure the evidence-based value of the asset is explained in J-CTD, Support scientific dialogue with HA for the innovation to be recognized for appropriate pricing and accelerated regulatory path. Project/Knowledge Management： + Ensure assigned projects are managed according to timeline e.g., through optimal communication paths with clinical development operation team. + Collaborate with Corporate CPL and Japan Evidence Network to acquire asset/CD (Clinical Development) strategic information includes HA interaction plans/documents to flawlessly execute CD activities in Japan. + TA-specific knowledge transfer to Medical Affairs function and other relevant business functions. Strategic Insights through EE (External Expert) engagement： + Engage with EE exchanging scientific/medical data and asset strategy to collect insights and inform asset CDP/AEP. + Assess assets’ profile with relevant Evidence Network function and EEs. Clinical Trial Support： + Provide scientific supervision/advice to the clinical dossier for Japan. + Provide trial sites recommendation based on the early and strategic engagement + Lead and support the PMDA clinical trial consultation and HA inquiry handling. + Lead the preparation/revision of IB for Japan and responsible for clinical part of the IB for Japan. **MA (Medical Advisor):** **Basic purpose of the job** **：** Contribute to execute CDMA (Clinical Development & Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy between start of preclinical development and late stages of commercialization. **Accountabilities** **：** + Strengthen NBI products’ profile by providing medical/scientific robust guidance in the responsible therapeutic area through the total process of the clinical development phases, in collaboration with BI corporate and other department. + Ensure and support Japanese submission and registrations in the respective products collaborating with regulatory/ clinical development team. (Support the clinical part until approval, such as preparation of responses to PMDA queries.) + Responsible for making Japanese clinical development plan recognized by BI global medicine as well aligned with global development strategy in the respective therapeutic area. + Support NBI make development/data building decision based on total picture (all projects/trials in the respects of resource/budget) in the therapeutic area. + Contribution to CDPs (Clinical Data Packages) after proof of concept and late stages of commercialization. + Prepare IAP (Integrated Asset Plan) and Detailed Annual Communication Plan to address Japan-specific needs, in collaboration with Marketing and Market Access, and aligned with the global IAP. + Build new scientific evidence by collaboration with external experts through clinical/pre-clinical research, investigator initiated studies and RWE (Real World Evidence) studies. + Contribution to benefit/risk evaluations of products. + Gain insight from external experts with MSL (Medical Science Liaison) and propose medical strategy. **Common requirement (CPL&MA):** **Job Expertise** **：** Full understandings of regulatory, clinical development, medical communication and compliance requirement in clinical development and medical affairs area. **Minimum Education/Degree Requirements** **：** Master's degree in life sciences. MD or PhD preferred. **Required Capabilities (Skills, Experience, Competencies)** **：** + Knowledge about the regulations related to clinical trials/clinical development is mandatory. Knowledge about clinical research/real-world evidence is preferred. + Experience in clinical development and regulatory interactions related to PMDA consultation, NDA filing, and product launch is mandatory. + Experience in leading team projects (evidence generation, new drug launch/approval, collaboration with external stakeholders) is preferred. + Experience in collaborating with and managing key opinion leaders and external experts is preferred. + Strong negotiation and communication skills for internal and external stakeholders in Japan and globally are required. + Good project management and excellent cross-functional collaboration skills with the ability to work with global matrix teams are required. + TA experience in a clinical or research setting, ideally in Nephrology, Cardiology, and Endocrinology, is preferred. + Conceptualization of research and writing scientific papers are preferred. + English speaking (at least TOEIC score >800). 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.