Education/Expertise/Working experience requirements:

1. Medical Degree or equivalent;

2. Clinical practice experience in medical oncology/hematology preferred but not required;

3. 3+ years of experience in designing, leading, and managing clinical studies in the field of oncology clinical research;

4. Industry experience in both global and China Studies highly desired;

5. Knowledge in ICH/GCP, FDA and CDE regulations;

6. Working knowledge in statistics, disease area, indication, competitive landscape, compounds;

7. Develop rapport with thought leaders and investigators;

8. Experience working effectively leading a team in a matrix environment;

9. Committed to quality and patient first;

10. Attention to details. Innovative and strategic;

11. Strong inter-personal and communication skills;

12. Foster team work.

Scope of responsibilities:

1. The position is expected to have hands on experience and knowledge clinical research;

2. The position is expected to independently lead clinical study (ies) with minimal supervision;

3. Design clinical studies based on up to date knowledge of disease, indication, competitive landscape, regulatory requirements to ensure meeting ethical and regulatory standards;

4. Responsible for the writing of protocol with support from CRS, stats, clinical operation, and clinical pharmacology/biomarker representatives;

5. Present on behalf of study team at investigator and DMC meetings as needed;

6. Assume overall responsibility for the quality, medical accuracy, and timeliness of the clinical study and clinical study reports;

7. Responsible for review and interpretation of study efficacy and safety data of assigned studies;

8. Responsible for present and discuss data with cross-functional teams, governance, thought leaders, and health authorities;

9. Responsible for the content of abstract, study reports, and manuscript of the assigned study;

10. Support regulatory documents in relationship to assigned studies (IB, IND clinical section, CTAs, DSUR, CTD summary documents, etc.);

11. Support and collaborate safety physician to ensure timely and accurate safety signal detection and reporting of assigned clinical studies;

12. Drive the development of Data Review Guideline with inputs from CRS, data management, clinical operation, and safety;

13. Define a feasible and disciplined data review plan with clear deliverables, timelines, and accountable persons identified;

14. Ensure timely data review per data review guideline and plan of assigned studies.