メディカルアドバイザー/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ィベロップメント・メディカルアフェアーズ心・腎・代謝領域メディシン第３部メディカルアフェアーズグループ

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 clinical development and late stages of commercialization.

Accountabilities

・Strengthen value of  our products by providing medical/scientific robust guidance in the responsible therapeutic area in collaboration with Global and other departments.

・Ensure and support Japanese submission and registrations in the respective products collaborating with regulatory/ clinical development team.

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

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

・Build new scientific evidence by collaboration with external experts through clinical/pre-clinical researches, external collaborative research 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 meetings. Ensure ethics and compliance. Plan strategically to allow for effective, safe & medically sound global preparation of drug commercialization efforts. Provide input and medical review of all internal 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 Medical subteam and local project team for registration. Ensure communication with CPL (Clinical Project Leader). Support obtaining preferable pricing.

Job Complexity

・Works in a cross-functional team including MSL, CPL, RA (Regulatory Affairs), PSPV (Patient Safety & Pharmacovigilance), BDS (Biostatistics & Data Sciences), Marketing, and Market Access. Requires driving cross-functional projects.

・Plays a key role in planning and leading medical strategy  initiatives in collaboration with internal and external stakeholders.

Interfaces

Integrated brand team, Local/Global R&D team members, Medical Affairs subteam, Team member global epidemiology, etc.

Job Expertise

・Full understanding of compliance requirement in Medical Affairs

・Expertise in people management is valued, but not mandatory. Capability to lead teams or works independently in planning and executing medical strategy is essential.

Minimum Education/Degree Requirements

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

Required Capabilities (Skills, Experience, Competencies)

・TA experience in clinical or research setting, ideally for nephrology or rare disease

・Experience in product launch are preferred

・Capability to conceptualize research projects, conduct basic and/or clinical research independently, and write scientific papers

・Experience collaborating with and managing key opinion leaders and external experts in relevant disease areas

・Strong negotiation and communication skills for both internal and external stakeholders, in Japan and globally

・Excellent project management and cross-functional collaboration skills, with the ability to work in global matrix teams

・Experience leading team projects (evidence generation, medical strategy, new drug launch/approval, collaboration with external stakeholders) ; people management experience is preferred.

・English proficiency (at least TOEIC >800)

・Knowledge of regulations related to clinical research, clinical trials, and clinical development

Regarding publications
・Please submit publication's title and Author.