Medical Advisor / Non-line Manager / Medical Affairs Group Oncology Med. Advisor/MSL

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: Solid tumors (especially gastrointestinal cancers).

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 solid tumors, especially gastrointestinal cancers (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.