SM/AD Clinical Research – Immunology (Late Phase)

About the role

The position focuses on clinical and regulatory strategy development, driving clinical development, expanding the portfolio, and accelerating registration of immunology products. It requires alignment with Global PDT and obtaining CDRC/LDRC endorsement, as well as execution of clinical and registration strategies. The role also involves regulatory interactions and preparation of clinical documents, while being accountable for protocol development, approval and amendment for China‑stand‑alone Phase I‑III studies and PMC.

Key responsibilities

• Drive the clinical development, expand the portfolio, and speed up registration.
• Obtain alignment with Global PDT and secure CDRC/LDRC endorsement.
• Execute clinical and registration strategy.
• Manage regulatory interactions and prepare clinical documentation.
• Accountable for protocol development, approval and amendment of China stand‑alone Phase I‑III and PMC.

Required skills

• Adverse Event Report
• Business Registrations
• Clinical Development
• Clinical Documentation
• Clinical Site Management
• Clinical Trial Documentation
• Clinical Trial Management
• Clinical Trials
• Clinical Writing
• Data Management
• Drug Regulatory Affairs
• Legal Document Preparation
• Patient Recruitment
• Pharmaceutical Quality Assurance
• Protocol Development
• Protocol Review