Clinical Scientist (Oncology) - Japan

About the role

GSK is looking for a Clinical Scientist (Oncology) in Japan who is responsible and accountable for the clinical scientific outputs of assigned projects and studies. The role covers about 2 to 4 projects at a time and works closely with Japan Development, Japan Regulatory Affairs, Japan Medical and other colleagues, as well as the global Medicines/Vaccines Development Team.

Key responsibilities

• Provide matrix leadership of the Japan clinical team (Clinical Science, Clinical Operations, Medical Writing, Biostatistics, Data Management) to ensure integrated planning and execution oversight.
• Lead Japan's clinical development strategy and plan, including clinical positioning, development plan and study design, to deliver differentiated medicines and vaccines.
• Review clinical study documents (protocol, informed consent form, case report forms, statistical analysis plan) and regulatory documents (CTD, briefing documents, responses to regulator queries).
• Act as a co-decision maker with Japan MDL/JVDL/CDL to resolve disputes within the clinical team.
• Work with the central clinical team on a global and Japan clinical development strategy, and represent the project internally and externally (regulators, ethics committees, healthcare professionals, patient groups).
• Produce evidence outputs: interpret study data for the Clinical Study Report, and prepare abstracts, posters and presentations for meetings, congresses and journals.
• Oversee quality and compliance in Japan clinical development, including risk management, and escalate issues where needed.

Required profile

• Japanese MD licence.
• Scientific, medical and regulatory knowledge of disease, treatments and guidelines.
• Experience contributing to projects and working with multiple stakeholders.
• High-level English and fluent Japanese.

Required skills

• Strategic assessment and decision making for clinical development plans and study designs.
• Solid understanding of clinical research and biostatistics principles.
• Ability to analyse and interpret moderately complex information using statistics and visualisation.
• Stakeholder management, matrix leadership and cross-functional collaboration.