Job Purpose
The Clinical Scientist (CS) in Japan is responsible and accountable for clinical scientific outputs for assigned projects and studies in Japan.
The CS will have accountability for approximately 2 - 4 projects (assets) at any one time and they will be required to work collaboratively alongside Japan Development, Japan Regulatory Affairs, Japan Medical and other J-MDT/VDT colleagues, as well as with global Medicines/Vaccines Development Team (MDT/VDT) and Clinical Sciences members to drive the ongoing success of the projects
Key Responsibilities
- Provide matrix leadership in Japan clinical team (Clinical Science, Clinical Operations, Medical Writing, Biostat, Data Management, etc.) to ensure integrated approach, robust planning, and execution oversight.
- Provide expert leadership and asset/disease expertise
- for Japan clinical development strategy and plan (e.g., clinical positioning, clinical development plan, clinical study design) to deliver differentiated medicine/vaccine of value for patients, stakeholders and markets in Japan.
- for Japan clinical study (e.g. Protocol, ICF, CTN, SAP) and clinical regulatory (e.g. CTD, briefing documents for consultation, and answers to queries from Regulatory authority) related documents.
- Serve as a co-decision maker (along with JMDL/JVDL/CDL) to resolve disputes among the Japan clinical team.
- Collaborate with central clinical team to create global/Japan clinical development strategy and plan that supports optimal medicine/vaccine development for Global as well as Japan.
- Represent the Japan clinical development of the project internally (e.g., central Clinical Science, functional leaders, senior managements, governance boards) and externally (e.g., MHLW/PMDA. EEs/HCPs, Patient Groups)
- Evidence Outputs: In terms of Japan analyses, interpret study data to create the scientific content of Clinical Study Report (CSR) and prepare the abstracts, posters and presentations for scientific meetings, congresses, external journal publications.
- Ensure quality & compliance oversight in Japan clinical development which align with R&D expectations, project needs, regulatory requirements including risk management, and escalate where required.
- Foster accountability culture: empower Japan clinical team members with clear ownership of tasks, support escalation when risks emerge, and celebrate delivery successes.
Knowledge & Skills
- Scientific, medical and regulatory knowledge including disease, treatment and guidelines.
- Strategic assessment and decision making skills for designing clinical development plans and clinical studies.
- Ability to interface with relevant scientific external stakeholders (e.g. regulators, EEs, CROs, investigators) to deliver clinical studies.
- Creative thinking skills for developing innovative business solutions.
- Solid understanding of clinical research and biostatistics principles to facilitate innovative and efficient clinical trial design with clear data-driven decision rules.
- Ability to use judgment, statistics, and visualization techniques to analyze and interpret moderately complex information.
- Ability to lead scientific interactions and respond confidently to complex questions using sound judgment.
- Knowledge about the importance of work undertaken in support of the medicine/vaccine vision and lifecycle management plan.
- Experience contributing to projects and working collaboratively with multiple stakeholders.
- Ability to research and use data from various sources to make robust fact-based decisions, employing diverse and critical thinking.
- High-level English and fluent Japanese communication skills.
※日本での就労資格を有すること
Preferred Qualification
Skil/Experience
- Development of clinical strategy, study design, and/or study protocol.
- Drug development experiences in oncology area
Education/Certification/Language
- Master of Science or equivalent. MD, PhD, PharmD preferred but not essential
※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。
Skills
Agile Thinking, Business Coaching, Change Management, Clinical Development, Clinical Research, Clinical Trial Management Systems (CTMS), Communication, Fostering Collaboration, Influencing Without Authority, Matrix Leadership, Project Management, Teamwork
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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