Japan Medicine Development Lead (J-MDL) - Specialty

About the role

GSK is looking for a Japan Medicine Development Lead (J-MDL) for a specialty medicine. The J-MDL is accountable for the development of a medicine in Japan, ensuring differentiated medicines of value for patients, stakeholders and markets. The role is the asset-level point of contact for the central Medicine Development Leader and the single point of contact to Japan senior management and the Japan governance board, and works closely with the central Medicine Development Team.

Key responsibilities

• Lead the central Medicine Development Team to create integrated development strategies for global and Japan, including the Integrated Evidence Plan and Medicine Profile.
• Act as single point of accountability for the medicine's development in Japan, from initiation to launch.
• Provide clinical leadership and asset/disease expertise for the clinical trial program and indications.
• Deliver medicines on time and within budget, with an evidence package supporting regulatory approval, market access and product life cycle.
• Provide matrix leadership of the Japan Medicine Development Team, own its performance and resolve disputes among members.
• Work with the Japan Early Development Leader, Japan Medical Lead and Japan Commercial Lead to ensure a smooth handover between development stages.
• Act as spokesperson to Japan senior management and the governance board, and engage external experts and professional societies.
• Identify unmet medical needs and prioritise portfolio options, including multiple indications.
• Recommend benefit-risk assessment, go/no-go criteria and clinical position to senior stakeholders.
• Create the external communication strategy and maintain relationships with regulators, government bodies, patient groups, CROs and scientific societies.
• Ensure quality, compliance, data and science standards, and oversee studies, pharmacovigilance, scientific engagement and promotion.
• Manage the asset's resourcing plan and budget in Japan.

Required profile

• Master's degree or equivalent; MD, PhD or PharmD preferred.
• Subject matter expert in neurology, immunology and/or cardiometabolic disease.
• Experience with early-phase clinical research and external engagements with KOLs and professional societies.
• Considerable pharmaceutical industry experience.
• Experience working with Japan regulators and their legal and government frameworks.
• Fluent in Japanese and English.

Required skills

• Clinical development and clinical trial design
• Matrix leadership, project management and risk management
• Strategic thinking, decision making and influencing without authority