Clinical Scientist, Senior CS or JCDL

Job Purpose

The Clinical Development Lead (CDL) in Japan is the single point of accountability for all clinical development activities for assigned asset(s). The CDL provides scientific and medical leadership to define and deliver Japan clinical strategy drives innovation and decisionmaking ensures compliance and quality and leads crossfunctional teams to achieve timely highquality development outcomes that deliver patient value. The CDL may also take responsibilities of Clinical Scientist (CS) when CS is not assigned.

Key Responsibilities

• Define and execute Japan clinical development strategy and local adaptations of global strategies informed by deep asset/disease expertise to deliver differentiated medicines/vaccines of value to patients stakeholders and the market.
• Lead benefitrisk assessments and provide evidencebased recommendations to central CDL senior management and governance boards on PoS go/nogo decisions and risk mitigation.
• Provide matrix leadership across Japan clinical functions (Clinical Science Clinical Operations Medical Writing Biostatistics Data Management etc.) to ensure integrated planning and robust execution oversight.
• Serve as the accountable decision maker to resolve disputes within the Japan clinical team and escalate where required.
• Act as a peer to central CDLs to align and optimize global clinical development strategy.
• Promote and implement innovative approaches (e.g. adaptive designs digital endpoints decentralised elements) to improve value speed and efficiency.
• Represent Japan clinical development internally and externally
• Oversee clinical development activities to ensure quality and ontime delivery.
• Coach and mentor CS and clinical colleagues to develop capability and a highperformance team.
• Foster crossfunctional decision making timely escalation and shared accountability.

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

Knowledge Skills & Experience

1. Significant clinical development experience in the pharmaceutical or vaccine industry (typically 58 years) including leadership of Japan clinical programs.

2. Demonstrated experience interacting with Japanese regulators (PMDA/MHLW) and local stakeholders.

3. Advanced degree in medicine pharmacy life sciences or equivalent (MD preferred).

4. Proven ability to lead crossfunctional matrixed teams and make highimpact decisions.

5. Track record in clinical strategy development study design and benefitrisk assessment.

6. Strategic and scientific leadership with strong therapeutic/asset expertise.

7. Excellent stakeholder management negotiation and influencing skills.

8. Strong problem solving risk management and decisionmaking capability.

9. Operational delivery focus with attention to quality and compliance.

10. Coaching and people development skills; ability to build highperforming teams.

11. Familiarity with innovative clinical trial design and digital/remote approaches.

12. Fluent in Japanese and businesslevel English (speaking and writing).

日本での就労資格を有すること

Success measures / KPIs

• Ontime delivery of Japan clinical milestones (studies initiated enrolment submissions).
• Quality of regulatory interactions and acceptance of clinical part of Japan submissions.
• Alignment and integration of Japan clinical strategy with global strategy.
• Team capability growth and retention; successful mentoring of CSs and other team members.
• Demonstrated adoption of innovative approaches that improve timelines or value.
• Establishment of peer-to-peer relationship with a counter global CDL

Additional Information

Travel: occasional domestic and international travel as required for regulatory meetings investigator sites and conferences.

This role operates in a matrixed environment and will require close collaboration with global MDT/VDT and crossfunctional Japan teams.

Skills

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 were 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 . Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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