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 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 researches, 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.

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 asset 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 Nephrology, Cardiology and Endocrinology.

・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 experts 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 score >800)

・Knowledge about the regulations related with clinical research/clinical trial/clinical development

Regarding publications

・Please submit publication's title and Author.

Recruiter : Tomatsu

Our Company

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths \u2013 and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after \u2013 as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com