Clinical Biomarker & Diagnostic Lead

Job Purpose

At GSK, we unite science, technology, and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. By bringing together outstanding people in an inclusive environment, we can make an impact on a global scale.

GSK is seeking an experienced Clinical Biomarker & Diagnostic Lead to support the continued growth of our Asia Translational Medicine organization and advance biomarker-driven clinical research & development, registration and reimbursement for oncology products in Japan.

In this Japan-focused role, you will partner closely with local, regional, and global colleagues across Asia Translational Medicine, Oncology Translational Medicine, Translational Research, Clinical Development, and Regulatory to design and deliver strategic, competitive, and scientifically robust clinical biomarker and diagnostic approaches aligned with global development strategies. You will bring deep expertise in clinical biomarkers and diagnostics to inform target engagement, mechanism of action, and patient selection, while incorporating Asia- and Japan-specific scientific, regulatory, reimbursement, and innovation landscape considerations.

You will lead the prioritization and execution of high-impact biomarker and diagnostic strategies in Japan - working closely across Asian regions and in collaboration with external laboratories and partners - to generate high-quality data and plan that enable clinical, regulatory and payor decision-making and support GSK’s global oncology portfolio across the product lifecycle.

This position will be based at one of GSK’s sites in Tokyo, Japan.

Responsibilities:

1. Lead Clinical Biomarker & Diagnostic Strategy in ATM (Oncology)

• Lead and contribute to clinical biomarker and diagnostic strategies and delivery across early- and late-stage Oncology programs to inform target engagement, mechanism of action, and patient selection.
• Ensure Japan biomarker & diagnostic strategies are aligned with global development plans, incorporating regional scientific, regulatory, and operational considerations.

2. Drive Clinical Biomarker & Diagnostic Execution & Data Delivery in ATM (Oncology)

• Oversee implementation of biomarker assays and testing strategies, ensuring timely, high-quality data generation to support clinical development, regulatory, and payor decision-making.
• Provide scientific input to clinical protocols, lab manuals, consent forms, and sample collection procedures, and serve as a point of contact for clinical biomarker & diagnostic technical issue resolution.
• Align with global precision diagnostic team and within Asia Translation Medicine on the diagnostics strategy in Japan to deliver translational medicine approaches to select patients for treatment.

3. Operate Effectively in a Matrixed Development Environment

• Act as a member of Japan oncology clinical matrix and study teams, representing clinical biomarker and diagnostic perspectives in regional and global forums.
• Communicate clear, timely biomarker data and insights to cross-functional and non-technical stakeholders to inform development decisions.

4. Enable Regulatory, External, and Innovation Impact

• Provide biomarker and diagnostic support for regulatory submissions and region-specific governance processes.
• Manage interactions with external laboratories, vendors, and collaborators, and maintain awareness of emerging biomarker technologies and innovation trends in Japan, establish scientific external partnership and conduct biomarker data analysis in close collaboration within Asia Translation Medicine and with global biomarker teams.

Impact:

This role strengthens Oncology clinical development across Asia by delivering high-quality, biomarker-driven insights that enable href="mailto:APACRecruitment.Adjustments@gsk.com">APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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