职位编号Job Code: CNCD04
职位 Position: Study Physician
部门 Department: Clinical Development
汇报关系 Reports to: Medical Science Director
办公地点 Location: Flexible
职位目标 Purpose or Objective of Position:
Study Physicians design and ensure successful conduct of clinical studies with the highest integrity in China and review study results. Study Physicians are core members of the Clinical Project Team and responsible for compounds in China’s development strategy and plan. Study Physicians also work with the US team on compound global development strategy and the conducting of global studies.
主要职责 Key Responsibilities：
- Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring).
- Develop, review and own documents (IB, protocol and CSR, etc.)
- Analyze and interpret clinical study results in partnership with Stats, Clinical Operations and Safety (as well as Clinical Pharmacologist, If necessary).
- Interact and communicate with China KOLs for China development strategy and protocol design.
- Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting including updating safety profile in the Investigator’s Brochure, Risk Management Plan, DSUR, etc.
- Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables.
- Set strategic direction for addressing medical issues in regulatory submission and communication/interaction.
- Be a clinical science expert and support China regulatory filing and registration.
- Provide consultation to clinical project team on protocol design questions and answer protocol related questions from site investigators.
- Medical degree, physician license is preferred.
- At least 3 years of relevant clinical working experience, either as a physician in a clinical development project, or medical advisor in medical affairs or clinical practice in hospitals.
- Medical expertise in related therapeutic areas.
- Good GCP knowledge and deep clinical trial related knowledge.
- Experience of study design and drug development plan.
- Experience of medical monitoring.
- Familiar with CSR content & data analysis.
- Fluent English and Chinese, written and oral.
- Solid presentation and communication skills.
- Can work independently, as well as on a team.
- Ability to collaborate cross-functionally.