Site Name: Japan - Tokyo - Akasaka Posted Date: Sep 24 2024 Job Purpose The Japan Medicine Development Lead (J-MDL) is accountable for medicine development in Japan to ensure delivery of differentiated medicines of value for patients, stakeholders and markets in Japan. The J-MDL serves as the asset level point-of-contact for central MDL, and asset single point of contact to Japan senior management and Japan governance board. Key Responsibilities 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. 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. Leads the multi-disciplinary matrix team in Japan (i.e. Japan Medicine Development Team); 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. Collaborates with the central Medicine Development Team (MDT) to create 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). 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. 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. Increases visibility amongst the external communities (physicians, regulators, patients, payers) in Japan, to bring medical solutions to patients with unmet medical needs, thereby enhancing reputation of GSK. 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. Accountable for delivering and managing the asset resourcing plan in Japan. In addition, the JMDL is accountable for managing the asset budget in Japan. 必要な条件Basic Qualification スキル/経験 Skill/Experience Considerable pharmaceutical industry experience is required. Filing experience, JNDA, as a core responsibility, as well as experiences of leading development programs in all phases of product development, especially in late phase development, are preferred. Experience of working with Japan regulators and regulatory requirements including an understanding of the legal and government frameworks. Matrix leadership skills Good personality to build collaborative team Knowledge/sense for risk management and governance Performance focus mindset Fundamental business acumen and strategic capability Innovative mindset based on scientific curiosity, logical and analytical thinking Fluent English proficiency 学位/資格/語学力 Education/certification/language Scientific degree or equivalent experience in life sciences, pharmaceutical, medical or equivalent. English communication skill in business level. 望ましい条件 Preferred Qualification スキル/経験 Skill/Experience Drug development experiences in oncology area 学位/資格/語学力 Education/certification/Language Master of Science or equivalent. MD, PhD, PharmD preferred but not essential Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. 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