Clinical Scientist (Respiratory and Immunology)

Job Purpose

The Clinical Scientist (CS) in Japan is the single point accountability for the development of the Clinical Development Plan (CDP) study design governance and interpretation of results of the studies and filing strategy and key messages in CTD (clinical modules) for Japan. The study design is expected to fulfil a strategic objective of the clinical development to maximize the asset values for Japan.

The CS will have accountability for approximately 2 projects (assets) at any one time and they will be required to work collaboratively alongside Japan Development Japan Regulatory Affairs and Japan Medical Affairs 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

• Single clinical development voice at the both program level & study level in Japan MDT/ VDT Japan Early Development Team (J-EDT) and other cross-functional collaboration with Japan Medical Affairs GAMA Japan Commercial functions etc.
• Lead Japan clinical development with global and local clinical leaders such as the Clinical Development Lead (CDL) Clinical Science Lead (CSL) Clinical Sciences members Study Delivery Lead (SDL) and Local Delivery Lead (LDL). Serves as the program and study level point-of-contact in Japan.
• Lead scientific interactions with external stakeholders (e.g. regulators EEs investigators) and work closely and collaboratively with CDL and CSL to input Japanese requirements and co-create integrated global development plan to maximize the asset values.
• Update and deliver Clinical Development Plan (CDP).
• Develop study (e.g. Protocol main ICF CTN (scientific contents)) & regulatory documents (e.g. CTD briefing documents for consultation and answers to queries from Regulatory authority).
• Study Design: Develop study design with CSL and clinical sciences members including integrated input from internal/external experts and patients in Japan.
• Scientific Oversight for the Study: Respond to scientific questions arising from sites in Japan to secure the quality of study during study conduct. Ensure that study analysis plan for Japan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and results.
• 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.

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.
• Business level English and Japanese.

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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