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 data-driven decision-making and translational medicine approaches. Through close partnership with regional and global teams, the Clinical Biomarker & Diagnostic Lead connects clinical programs from Asia to global development priorities and accelerates translation of science into meaningful patient outcomes.

Why You?

You are an experienced clinical biomarker and diagnostic scientist with deep expertise in biomarkers and diagnostic assays and a strong understanding of diagnostics development, registration and reimbursement requirements in Japan. You thrive in matrix environments, communicate clearly, and deliver results with rigor and urgency in fast-paced development settings.]

Basic Qualifications

• PhD (or MS) with minimum of 8 years relevant industry experience in the application of clinical biomarkers and diagnostics in clinical trials preferably in Oncology.
• Relevant experience applying clinical biomarkers and diagnostic assays in clinical trials within pharmaceutical or biotech clinical development.
• Demonstrated experience analyzing and interpreting clinical biomarker data to inform development decisions.
• Strong working knowledge of biomarker technologies, assay platforms, and GCP principles.
• Proven ability to operate effectively in matrixed, cross-functional teams.
• Proficient in both English and Japanese.

Preferred Qualifications

• Experience supporting development programs in Oncology, especially diagnostics development, registration and reimbursement in Japan.
• Hands-on experience in IHC and NGS assays, with deep understanding of bioinformatic analysis as a plus.
• Familiarity with Japan and global regulatory expectations for biomarkers and diagnostics.
• Experience managing external laboratories, vendors, or research collaborations in Japan.
• Demonstrated scientific contribution through publications, presentations, or external collaborations.

※職務内容および勤務地の変更範囲は会社の定めるところとする。

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. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact 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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