Understand global/Chinese new drug development policies and processes, write clinical documents for IND applications like investigator's brochures, clinical study summaries, discuss with experts to refine clinical study protocols.
Assist in resolving clinical implementation issues alongside regulatory and clinical operations teams, including patient enrollment, adverse event management, medical data monitoring, trial data analysis, and medical document review.
Provide medical research information support, proficient in common clinical trial design methods for new drugs, and coordinate external expert resources to develop scientifically sound clinical strategies for product development.
Master's degree or above in a clinical field, oncology preferred.
2-3 years of experience in medical work for clinical trials of small molecule innovative cancer drugs, experience in pre-marketing clinical trial design, medical monitoring, and support preferred, those with over 3 years of clinical department experience are also preferred.
Understanding of drug development concepts, techniques, and regulatory requirements.
Experience in clinical trial medical monitoring and clinical study report writing.
Strong execution and teamwork skills, resilience, continuous learning ability, and proficiency in English.