1. Maintain scientific and clinical knowledge in the specific therapeutic and disease areas especially hematologic malignancy or cell therapy.
2. Contribute to the clinical development strategy for the relevant therapeutic/disease areas;
3. Conduct literature searches and analyze the data and information necessary to create the clinical development plan;
4. Take medical responsibilities for clinical trials;
5. Develop clinical study design for internal reviews;
6. Provide support to clinical operation and other groups to develop Informed Consent Form (ICF), Case Report Form (CRF), CRF instructions, etc.
7. Review and/or write additional clinical science documentation and/or provide clinical science input into other documentation managed by other groups;
8. Collaborate with data management and other groups to conduct medical review of study data, identify and evaluate the data outliers and query the sites;
9. Collaborate clinical operation and other groups to identify and evaluate the protocol deviations;
10. Review the study report and respond to authority’s inquiries;
11. Prepare or review abstracts, posters, and content for scientific events etc.
12. Collaborate with regulatory and other team to complete and submit regulatory filings and other regulatory documentation;
13. Collaborate with PV to review safety data and provide medical support and judgement to ensure the high standards of clinical safety;
14. Provide medical support to Commercial, Market Access, Regulatory, Legal Counsel, et al.