Physician II (Cell Therapy)
On-site · Shanghai, Shanghai, China or Beijing, Beijing, China
Job Summary
Physician II (Cell Therapy) will lead and support in-scope clinical studies, co-owning study delivery with BIS/Clinical Operations, developing and maintaining critical documents (CIB, protocol, CSR), and analyzing clinical results in partnership with cross-functional teams. The role includes advisory board formation for portfolio projects, interaction with China KOLs for development strategy and protocol design, safety/PK-PD collaboration with safety physicians and clinical pharmacologists, and ensuring regulatory compliance and medical direction across China product initiatives. The physician will contribute to regulatory submissions and early market access activities, provide clinical science expertise to QA/BD teams, and stay current on medical and scientific developments relevant to cell-therapy programs. This is a senior, global pharma leadership position at AstraZeneca with emphasis on medical monitoring, protocol development, regulatory interactions, and cross-functional collaboration with China teams.
Required Qualifications
- MD or PhD
- Minimum 6 years of experience as clinical research physician in pharma industry
- Therapeutic area expertise in Cell-Therapy/Immunology/Oncology
- Regulatory guidance for the TA
- Safety reporting and Risk Management
- CSR content & data analysis
- PK/PD knowledge
- Protocol development for review by Clinical Challenge and Protocol Review Committee
- Strong communication/presentation skills
- Experience liaising with regulatory officials and China KOLs
- Be a TA clinical science expert in China projects
- Liaise with BD/MA for pre-launch activities
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