Japan Medicine Development Lead (J-MDL) Specialty

【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. Minimum Level of Job-Related Experience & education ⚫ Master of Science