Location: Shanghai/Shenzhen, China
1. Responsible for the project management of clinical research and development of new drugs in China, and to carry out relevant research on new drugs of Class I according to relevant requirements of CFDA, FDA and ICH;
2. Communicate and coordinate with domestic and overseas partners and carry out research and development as planned;
3. Responsible for external communication with CRO and clinical institutions and project promotion;
4. Responsible for the internal inspection and quality control of all projects (regardless of treatment field), and to ensure that clinical trials of various projects are strictly carried out in accordance with national regulations, clinical trial plans and SOP of the Company.
1. Master degree or above in medicine, pharmacy or related major;
2. At least 5 years of clinical research and development experience in new drugs, at least 3 years of clinical project leader experience, Class I new drug research and development experience is preferred;
3. Rich experience in leadership and project management;
4. Familiar with SFDA, FDA and ICH's relevant requirements for the research of Class I of new drugs is a MUST;
5. A good command of English (reading and writing). You can communicate directly with overseas partners in English and be able to adapt to an all-English office environment.
6. Be active and independent work, and cooperate with other departments of the company to carry out projects;
7. Powerful adaptability to work under time constraints and task pressures
8. Requirements for computer skills: Proficient in basic computer knowledge, proficiency in operating Chinese and English operating systems, and proficiency in the application of office automation software.