Shenzhen/ Shanghai, China
• Manage on-going clinical study.
• Provide clinical/scientific inputs during the development and execution of clinical trials
• Responsible for patient enrollment and manage and monitor drug safety.
• Participate in interactions with regulatory agencies.
• Prepare the required regulatory interaction documentations for clinical trials, including study synopsis, protocols, investigator brochure, study safety report, and study report. Review any relevant regulatory documents, including CRF, ICF, DSUR, SUSAR and CIOM.
• Ph.D. or MD degree in medicine related fields, overseas degree is preferred;
• At least 8 years`experience in medical institutions, pharmaceutical companies, or CRO clinical related work experience; clinical science experience in the field of oncology or immunology is preferred;
• Ability to independently formulate clinical development strategies and writing medical protocols
• Rich experience in early clinical development program, familiar with domestic and US laws and regulations