Job Description

【応募要件】

臨床試験の経験は必須、企業経験（3-5年以上）があり開発経験があるMD（日本医師免許）保持者限定

経験によりClinical Science LeadもしくはSr. Clinical Scientistでの採用となる可能性あり

1. Assume overall responsibilities as a regional/country level Development Team leader in the matrix setting to ensure alignment across key stakeholders and promote team work.
2. Drive the development of Clinical Development Plan (CDP) and relevant study designs through team effort; ensure input from internal or external expertise is integrated and reflected in the CDP. Such expertise may include but not limited to key opinion leaders, global Patient Value Unit, regulatory affairs experts, project/study physicians, project management, biostatisticians, and pharmacologists.
3. Be responsible for overall implementation of the CDP to ensure timelines, budget as well as deliverables are within expectation.
4. Co-author and/or review protocol concept / protocol, other study-related clinical documents according to the CDP, and scientific publications.
5. Ensure that medical science is well incorporated into the clinical development strategy, plans and study designs.
6. Guide the team through data analyses and review to conclude for study result interpretation.
7. Serve as the leader in logic construction in clinical for various submissions across the region, such as CTD/eCTDs, CTAs/CTNs and NDAs or IDLs.
8. Contribute to establish “Center of Excellence” in clinical development in Asia.

[If the person is M.D. and it requires]

1. Oversight CRO's medical monitoring activities and educate medical monitors

Contribute to safety evaluations to ensure participating patients’ safety in clinical studies.