CPL+MA（心不全・CKD領域） / ノンラインマネージャー or  スタッフ / 医薬開発本部クリニカルデベロップメント・メディカルアフェアーズ心・腎・代謝領域メディシン第１部

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).