Japan Medicine Development Lead (J-MDL) Specialty

Job description

【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 or equivalent. ⚫ MD, PhD, PharmD preferred ⚫ 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 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 Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. 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