**Basic purpose of the job** To 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 Nippon Boehringer Ingelheim 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 Boehringer Ingelheim 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 Boehringer Ingelheim global medicine as well aligned with global development strategy in the respective therapeutic area ・Support Nippon Boehringer Ingelheim 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 Integrated Asset Plan & Detailed Annual Communication Plan to address Japan specific needs, together with Marketing and Market Access & aligned with global IBP (Integrated Brand Plan) ・Build new scientific evidence by collaboration with external experts through clinical/pre-clinical researches, investigator initiated studies and RWE (Real World Evidence) studies. ・Contribution to benefit/risk evaluations of products. ・Gain insight from external expert with MSL (Medical Science Liaison) and propose medical strategy. **Regulatory and / or Organizational Requirements** Contribute to Strategy and Activity Review Committee meetings. Ensure ethics and compliance. Ensure re-examination by reviewing documents and process. Plan strategically to allow for effective, safe & medically sound global preparation of drug commercialization efforts. Provide input and medical review of all in- and external documentation prepared by Marketing and Public Relations. Define trials needed to answer relevant questions regarding our products and their related development projects to meet regulatory and payer requirements and our commercial needs build upon from the trial’s concepts developed by the MST (Medical Subteam) & LPT (Local Project Team for Registration). Provide medical input into epidemiology studies. Ensure communication with CPL (Clinical Project Leader). Support to obtain preferable pricing. **Job Complexity** Work in a cross-functional team including MSL, CPL, PV (Pharmacovigilance), BDS (Biostatistics & Data Sciences), Marketing, Market Access **Interfaces** Integrated brand team, rapid response team, MST, MAST (Medical Affairs Subteam), Team Member Global Epidemiology, local R&D team members **Job Expertise** Full understandings of regulatory, clinical development, medical communication and compliance requirement in Medical Affairs **Minimum Education/Degree Requirements** Master's degree in life sciences. MD or PhD preferred. **Required Capabilities (Skills, Experience, Competencies)** ・TA experience in clinical or research setting, ideally for hepatology, cardiology and Nephrology. ・Experience in clinical development and regulatory interactions related to PMDA consultation and NDA filing and product launch are highly preferred. ・Conceptualization of research and writing scientific papers ・Experience in collaborating and managing key opinion leaders and external exports in respective disease area ・Strong negotiation and communication skills for internal and external stakeholders in Japan and global ・Good project management and excellent cross functional collaboration skills with ability to work with global matrix teams ・Experience in leading a team project (evidence generation, new drug launch/approval, collaboration with external stakeholders) / people management are preferred . ・English speaking (at least TOEIC >800) ・Knowledge about the regulations related with clinical research/clinical trial/clinical development **Regarding publications** ・Please submit publication's title and Author. **Recruiter : Tomatsu** 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.