☑English language required
☑Japanese language required
Clinical Scientist (Oncology)
- 世界 150 カ国で事業展開しているグローバルヘルスケア企業
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 a study, and filing strategy and documents of clinical part for Japan. The study designed is expected to fulfill a strategic objective of the clinical development or integrated evidence plan for Japan. The CS will have accountability for up to 2 projects at any one time and they will be required to work collaboratively alongside Japan Medical and Development colleagues, as well as with global Medicines Development Team (MDT) to help drive the ongoing success of the projects
- Single clinical development voice at the study level (if program level: Lead CS) into Japan Project Team (JPT), 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 Clinical Development Plan (CDP). Develop filing documents (e.g. CTD, briefing documents for consultation, and answers to queries from Regulatory authority, etc).
- Study Design: Develop study with CSL, including integrated input from internal/external experts, thought leaders and patients in Japan. Present the scientific rationale and study design at Investigator Meetings in Japan and respond to scientific questions arising from sites in Japan 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. Consult with Japan medical governance relating to study design and Japan regulation and execute, by having consultant with internal/external medical specialist.
- 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)
- Collaborate as a partner with global and local clinical leaders such as the Study Delivery Lead (SDL), Clinical Science Lead (CSL) and Local Delivery Lead (LDL). Serves as the study level point-of-contact in Japan for the CSL.
- Scientific degree or equivalent experience（Area of Specialization：Life sciences, Pharmaceutical, Medical or equivalent）
- Pharmaceutical industry experience.
- Experience developing study design and protocol.
- Experience working with relevant scientific external experts (e.g. Japan regulators, CROs, investigators).
- Experience leading study matrix team or joining as a core member
[Preferred Knowledge, Skills and Abilities]
- Master of Science or equivalent. MD, PhD, PharmD （Area of Specialization：Life sciences, Pharmaceutical, Medical or equivalent）
- English Language level: Business level
- Japanese Language level: Fluent - Native Level (Equivalent to JLPT N1)
- Work permission in Japan required
10〜14 million JPY
※Experiences and skills will be considered
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Seniority Level: Mid-Senior level
Job Function: Health Care Provider