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The Japan Medicine Development Lead (J-MDL) is accountable for a medicine development in Japan, from initiation of Japan development through launch in Japan. The role leads collaboration with the central Medicine Development Team and provides clinical leadership and asset/disease expertise. The J-MDL is also accountable for the asset resourcing plan and budget in Japan.

応募資格・募集要項・仕事内容を見る

応募資格

必須

Master of Science or equivalent.
Subject matter expert in neurology, immunology and/or cardiometabolic disease
Experienced in external engagements with KOLs and professional societies
Experience with early phase clinical research
Considerable pharmaceutical industry experience is required
Experience of working with Japan regulators and regulatory requirements including an understanding of the legal and government frameworks
Fluent in Japanese and English
Great communication and influencing skills
Agile Thinking
Clinical Development
Clinical Trial Designs
Decision Making
Fostering Collaboration
Influencing Without Authority
Leadership
Matrix Leadership
Mentorship
People Management
Project Management
Risk Management
Strategic Thinking
Teamwork
Time Management

歓迎

MD, PhD, PharmD preferred

募集要項最終確認 11/6

職種: 臨床開発・薬事
雇用形態: 記載なし
役職: Japan Medicine Development Lead (J-MDL)
給与: 記載なし
勤務地: Japan - Tokyo - Akasaka
働き方: 記載なし
学歴: 大学院修了以上
掲載日: 2026/11/06 23:09（2日前）
最終確認: 2026/11/06 23:09（2日前）

仕事内容

Job Purpose

The Japan Medicine Development Lead (J-MDL) is accountable for a medicine development in Japan to ensure delivery differentiated medicines of value for patients, stakeholders and markets in Japan. The J-MDL serves as the asset level point-of-contact for Medicine Development Leader (=MDL), and asset single point of contact to Japan senior management and Japan governance board. JMDL must work closely with MDL not only successful launch for Japan but also overall success for GSK Global as one of the key leaders in Global Medicine Development Team (=MDT).

Key Responsibilities

⚫ Provide leadership and collaborates with the central Medicine Development Team (MDT) to create overall integrated development strategies that support optimal medicine development for Global as well as Japan, including Integrated Evidence Plan (IEP) and Medicine Profile. Serves as the asset level point-of-contact for the central Medicine Development Leader (MDL).
⚫ Acts as a single point of accountability for all aspects of a medicine development in Japan from initiation of Japan development to launch in Japan. Provide clinical leadership and asset/disease expertise for the clinical trial program and indications in scope
⚫ Delivers differentiated medicines of value for patients, stakeholders and markets in Japan on time within budget, through an evidence package that supports regulatory approval, market access, and product life cycle in Japan.
⚫ Provide Matrix Leadership in Japan (i.e. Japan Medicine Development Team) to ensure integrated approach, robust planning, and execution oversight. Also supports differentiated development for team members; owns the performance of J-MDT and partners with line managers to drive performance. Serves as the single accountable decision maker to resolve disputes among the J-MDT.
⚫ Works closely with the Japan Early Development Leader (J-EDL) as well as Japan Medical Lead (J-MAL) and Japan Commercial Lead (JCL) to ensure a smooth transition between the J-EDL (accountable from C2CS to initiation of Japan development) to J-MDL (accountable from initiation of Japan development to the first approval in Japan) and from J-MDL to J-MAL/JCL (accountable after the first approval in Japan).
⚫ Asset single point of contact and spokesperson to Japan senior management and Japan governance board (e.g. Portfolio Investment Board Japan).
⚫ Engages with external experts and professional societies to gain insights to design and deliver clinical development strategy.
⚫ Proactively identifies unmet medical needs that could be addressed through line extensions in Japan. Prioritizes and maximizes the asset’s portfolio options including developing multiple indications in Japan.
⚫ Responsible for making recommendations to TAL/IET Leader and senior stakeholders on benefit risk assessment, Go/No-go criteria, and Clinical PoS for the program in scope
⚫ To create the communication strategy and represent GSK externally and keep good relationship with Regulatory and government organisations
Ministry of Health, Labor, and Welfare, PMDA
Japanese Government (Cabinet minister, Minister office)
National Center, Researech Institute (National Cancer Hospital etc) Scientific Societies, EEs
Patient Groups
CRO
⚫ Ensures quality & compliance oversight in line with R&D expectations and project needs; assures quality of data and science. Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement and promotional practices.
⚫ J-MDL is accountable for delivering and managing the asset resourcing plan in Japan. In addition, the J MDL is accountable for managing the asset budget in Japan.

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