- The Clinical Scientist (CS) is the single point accountability for the development of the Clinical Development Plan (CDP) and study design, interpretation of study results, as well as creation of filing strategy and documents of clinical part.
- Single clinical development voice at the study level (if program level: Lead CS) into Japan Project Team, Japan Early Development Team (J-EDT), Japan Medical Affairs, and Japan Commercial functions.
- Lead scientific interactions with external experts (e.g. regulators, CROs, investigators), and work closely with CDL to input Japanese requirements into one development plan.
- Create and deliver CDP. Develop filing documents (e.g. CTD, briefing documents for consultation, and answers to queries from Regulatory authority, etc).
- Study Design: Develop study design, including integrated input from internal/external experts, thought leaders and patients in Japan. Present the scientific rationale and study design at Investigator Meetings and respond to scientific questions arising from sites during study conduct.
- Scientific oversight for the study: 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 generation & 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. Prepare clinical content of regulatory documents and interaction with Japan regulatory authorities (e.g., CTN, PMDA consultation, CTD)
- Pharmaceutical industry experience, particularly in drug development.
- Familiar with clinical study process and Japan regulation related to drug approval.
- Working with relevant scientific external experts (e.g. Japan regulators, CROs, investigators).
- Leading study matrix team.
- Logical thinking
- Logical communication skill
- Scientific degree or equivalent experience in life sciences, pharmaceutical, medical or equivalent.
- English communication skill in business level.
- Development of clinical strategy, study design, and/or study protocol.
- Drug development experiences in oncology area
- Master of Science or equivalent. MD, PhD, PharmD preferred but not essential
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Clinical Scientist - Minato, 日本 - 711 GlaxoSmithKline K.K.
説明
Job Purpose:
Key Responsibilities:
Basic Qualification:
Experience
Skill
Education/Certification/Language
Preferred Qualification:
Skill/Experience
Education/certification/Language
Why Us?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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