・Applicants must have permission to work in Japan
・Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
☑Foreign business ☑English language required ☑Japanese language required ☑Remote ☑Flex time
Oncology - Clinical Scientist
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: Life sciences, Pharmaceutical, Medical or equivalent
Why is it required?
This role requires a good understanding of scientific and medical information and an ability to apply this understanding to create study plan as well as execution.
Previous Experience Required
- 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.
Why is this level of experience required?
The one of the key responsibilities of the role is to contribute to develop and execute CDP from the scientific view. In order to deliver differentiated medicines in Japan, obtaining various scientific inputs from external experts is essential. Also, study process and regulation are complex, and thus, work as one team is key to success
- Master of Science or equivalent. MD, PhD, PharmD preferred but not essential: Life sciences, Pharmaceutical, Medical or equivalent
Why is it required?
This role leads a scientific aspect of study in Japan in collaboration with external physicians and regulatory authorities and must be able to intelligently convey our positions and requirements to a highly educated external partner group.
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Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Science