Medical Director
Drafts development plans, clinical documents under guidance. Represents Clinical Development on Study Team and collaborates as team member with other functions and/or vendors. Provides clinical data analysis and scientific input to Clinical Operations and other functions. This position provides critical support to the Clinical Development functions.
Responsibilities：
• Study Strategy: Drafts development plan under guidance or independently. Contributes critical aspects of study design, providing strategic direction to other functions such biomarkers, PK, stats etc. as needed. Performs literature review and creates reference list for study.
• Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables; development of contingency plan; development of protocol documents; selection of vendors; development of charters for study committees. Provides input to Clinical Operations on monitoring plan and to Biostatistics on Statistical Analysis Plan.
• Study execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews/analyses emerging clinical data regularly and provides scientific input; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.
• External collaboration: Assist in Consulting with internal experts and external KOLs for protocol development; provides input on Vendor’s Scope of Work and budget; participates in study team meetings with vendors; establishes effective communication with vendors.
• Additional non-study related activities: Clinical Development involvement in due diligence activities related to in-licensing and acquisitions. Performs literature review related to new indications.
Education and Experience Qualifications：
• Degree in medicine, PhD or equivalent
• 5-10 years of clinical development
• Experience in breast cancer research preferred
• Experience working with clinical-related research preferred
• Strong analytical and communication skills highly desirable
Work Location:
• Full-time positions are based in Shanghai.
Competitive packages
