メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

[Job Purpose]
The Japan Vaccine Development Lead (J-VDL) is accountable for a vaccine development in Japan to ensure delivery differentiated vaccines of value for patients, stakeholders and markets in Japan. The J-VDL serves as the asset level point-of-contact for Vaccine Development Leader (=VDL), and asset single point of contact to Japan senior management and Japan governance board. JVDL must work closely with VDL not only successful launch for Japan but also overall success for GSK Global as one of the key leaders in Global Vaccine Development Team (=VDT).
[Key Responsibilities]
• Provide leadership and collaborates with the central Vaccine Development Team (VDT) to create overall integrated development strategies that support optimal medicine development for Global as well as Japan, including Integrated Evidence Plan (IEP) and Vaccine Profile. Serves as the asset level point-of-contact for the central Vaccine Development Leader (VDL).
• Acts as a single point of accountability for all aspects of a vaccine 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 vaccines 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 Vaccine Development Team) to ensure integrated approach, robust planning, and execution oversight. Also supports differentiated development for team members; owns the performance of J-VDT and partners with line managers to drive performance. Serves as the single accountable decision maker to resolve disputes among the J-VDT.
• 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-VDL (accountable from initiation of Japan development to the first approval in Japan) and from J-VDL 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).
• 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（PPD）
• 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-VDL is accountable for delivering and managing the asset resourcing plan in Japan. In addition, the J-VDL is accountable for managing the asset budget in Japan.

■休日：完全週休二日制, 年末年始

Minimum Level of Job-Related Experience & education
• Master of Science or equivalent.
• MD, PhD, PharmD preferred
• Vaccine development experience in the Japan market preferred
• Considerable pharmaceutical industry experience is required
• Filing experience, JNDA as a core responsibility and have led development programs and deep experience in all phases of product development, especially in late phase development is preferred
• Experience of working with Japan regulators and regulatory requirements including an understanding of the legal and government frameworks
• High-business level Japanese and English

■職種未経験者：不可