JOB SCOPE
1. Responsible for SOP of Medicine Clinical;
2. Plan, develop, oversee and monitor progress of clinical development projects;
3. Evaluate the safety information of the project and ensure the regulatory compliance of the safety report;
4. Track and analyze the domestic and foreign medical trends and scientific research trends of cell therapy, and understand the progress and trends in the field;
5. Establish good cooperative relations and conduct professional communication with clinical experts and researchers, clinical trial institutions, CROs and other partners;
6. Contribute medical inputs to clinical protocols, institutional review board submissions, study reports, regulatory documents and scientific manuscripts;
7. Act on behalf of the Biosyngen team, as assigned by the management;
EXPERIENCE REQUIREMENTS
1. Professional background in the medical or life sciences (e.g. MD, Ph.D., PharmD, pharmacist), ideally with a minimum of 10 years in a pharmaceutical or biotech company, or public healthcare institution;
2. Able to independently design and write medical plans, minimum of 5 years of clinical medical plan writing experience;
3. Competency in the conduct and monitoring of clinical trials and clinical development projects, including the regulatory submission process and guidelines;
4. Familiarity with oncology clinical research and therapeutic development. Prior experience with immune oncology projects will be an advantage;
