1. Responsible for the specific implementation and execution of clinical research for ongoing projects

2. Assist in carrying out various tasks related to clinical trials to ensure their smooth progress

3. Responsible for writing clinical trial related materials for ongoing projects (including IND application medical materials and ethical materials, etc.);

4. Responsible for communicating important project related matters with clinical CROs and researchers;

5. Responsible for clinical efficacy and safety data analysis, and can provide support for the subsequent development strategy of the project;

6. Responsible for reviewing the clinical trial summary report, reviewing the data during the clinical trial process, raising medical questions, and proposing solutions.

1. Participate in the research and development of the company's product line, responsible for conducting research and development experiments, including screening targets related to tumor therapy Establishing stable cell lines, characterizing and identifying extracellular vesicles, and ultimately obtaining extracellular vesicle drugs with anti-tumor efficacy;

2. Coordinate the different stages involved in R&D and input data Management and statistical analysis;

3. Based on the company's development needs, through preliminary research and tracking of hot topics, combined with experimental research, provide scientific and experimental basis for the company's new drug development and project approval, and write relevant research reports;

4. Responsible for cutting-edge tracking, literature research, and continuous development of candidate new drugs;

5. Responsible for coordinating and tracking work within the company to ensure the smooth progress of the project

1. Responsible for the process development of new drugs in the clinical stage of the company;

2. Develop research plans for CMC, manage CDMO/CRO, and monitor the entire process and project execution of CMC development.

3. Responsible for connecting upstream research and development with downstream production, communicating and coordinating with relevant personnel in a timely manner, carrying out process technology transfer and SOP development, scaling up product scale, developing large-scale production process parameters, and quality standards;

4. According to the relevant regulations on drug registration, write and review IND/BLA pharmaceutical related materials.

1. Mainly responsible for the implementation of biological analysis and testing experiments related to our company's products, such as: ELISA,qPCR, Virus titer testing, extraction of genomic DNA, etc;

2. Responsible for implementing the validation experiments of biological analysis methodology Optimization;

3. Responsible for investigating and analyzing laboratory deviations/changes/OOS records related to the testing process, and promptly reporting any abnormal situations;

4. Responsible for daily testing and key reagents used in the production process Molecular biology related experiments in material release inspection;

5. Responsible for writing GMP documents such as SOP for molecular biology related analysis methods, management SOP, method validation or confirmation plans and reports;

6. Conduct daily laboratory activities in accordance with QC laboratory regulations and relevant regulatory requirements

7. Need to assist in completing other QC testing related work