Basic purpose of the job

To plan and execute CDMA (Clinical Development & Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy. Confirmed target indication: Obesity disease, MASH (Metabolic dysfunction associated steatohepatitis).

Accountabilities

・Gain insight from external expert (EE) with MSL (Medical Science Liaison) and propose medical activity based on identified medical gap.

・Build new scientific evidence by collaboration with external experts through clinical/pre-clinical researches, investigator initiated studies and RWE (Real World Evidence) studies including PMS.

・Prepare Integrated Asset Plan (IAP) & Detailed Annual Communication Plan to address Japan specific needs, together with Marketing and Market Access & aligned with global IAP.

・Support NBI make development/data building decision based on total picture (all projects/trials in the respects of resource/budget) in the TA.

・Strengthen NBI products' profile by providing medical/scientific robust guidance in the responsible TA 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 TA

・Contribution to CDPs (Clinical Data Packages) after proof of concept and late stages of commercialization with medical perspective.

・Contribution to benefit/risk evaluations of products.

・To understand and comply with regulations and industry rules (promotional codes, fair competition rules, privacy, data collection/storage, etc.) as well as related SOP.

Job Complexity

Work in a cross-functional team including MSL, CPL, PV (Pharmacovigilance), BDS (Biostatistics & Data Sciences), Marketing, Market Access in local and global team.

Interfaces

Integrated brand team, rapid response team, MST, MAST (Medical Affairs Subteam), Team Member Global Epidemiology, local R&D team members

Job Expertise

Understandings of regulatory, clinical development, medical communication and compliance requirement in Medical Affairs

Minimum Education/Degree Requirements

A Master's degree in life sciences. MD or PhD is preferred.

Capabilities (Skills, Experience, Competencies)

・Good communication and negotiation skills for internal and external stakeholders in Japan and global (required).

・TA experience in clinical or research setting, ideally for a liver-related disease and metabolic diseases such as obesity and diabetes (strongly preferred).

・Experience in collaborating and managing key opinion leaders and external exports in respective disease area (preferred).

・Experience in conceptualization of pre-clinical or clinical research and in developing scientific manuscript (preferred).

・English communication skills (preferred CEFR B2 or above).

・Experience in medical product launch is plus.

・Knowledge about the regulations related to clinical research/clinical trial/clinical development is plus

・Experience in clinical development and regulatory interactions related to PMDA consultation and NDA filing and product launch are plus.

Regarding publications
・Please submit list of key publications, if possible I relation to this field.