I-Mab Biopharma

Medical Director

• Design study protocols and clinical development plans in collaboration with cross-functional teams both in the US and China, in oncology or autoimmune therapeutic areas.
• Author key clinical sections of IB, IND submissions, regulatory briefing books, Annual Reports, CSR; prepare strategy presentations; present and discuss data with governance, external consultants, KOLs and within regulatory meetings in conjunction with members of the development team.
• Create and/or review study documents/plans including monitoring plan, data management plan, safety review plan, etc.
• Perform ongoing data reviews and assume leadership of safety review meetings.
• Communicate internally and externally both orally and in writing on clinical trial design and results.
• Analyze and synthesize clinical data for publication, conduct and evaluate clinical trials.
• Proactively identify clinical development risks and propose risk mitigation solutions.
• Supervise project team members in planning, conducting, and evaluating clinical trials.
• Serve as medical monitor with significant responsibility for safety surveillance.
• Collaborate with R&D function and senior management in assessing requirements for emerging products, including next generation candidates.
• Identify, select, and train clinical research centers and investigators.
• Oversee planning and management of investigator meetings, advisory boards and other scientific committees as required by the protocol (e.g. independent reviews, DSMB’s etc.).
• Participate in the selection of sites, CROs, and vendors.

Senior Medical Director