Provide leadership and experience in conducting early clinical research in China.
Develop products towards registration, including study protocol, engaging key opinion leaders, drafting study reports, and preparing regulatory submissions.
Collaborate with headquarter project teams and clinical trial operations for the execution of early studies.
Represent clinical development team and address issues/questions raised by headquarters team from China perspective.
Drive study design, collaborate with biostatisticians and regulatory affairs to construct high-quality clinical study protocols.
Review and prepare clinical study reports and regulatory dossiers.
Requirements
A PHD/Master in clinical medicine (at least 5-year medical school graduates) with postgraduate training in oncology or relative major.
Deep understanding of China regulatory environment and clinical development procedure.
Previous experience of clinical research/clinical development is highly desirable, including strategy development, medical monitoring, and protocol/ writing.
Strong leadership, excellent written and oral communication skills, and project management skills.
Strong capability of work prioritization and deliver results with parallel multiple tasks.
Excellent language skills in both English and Chinese (fluent in verbal and written).