工作职责:
1.1 To support line manager for compound development feasibility and strategy analysis, engage in compound clinical development strategy and plan.
1.2 To support line manager for study design, clinical trial protocol, publication plan, provide medical expertise in developing clinical trial reports, summary documents, investigator's brochure, and medical relevant documents.
1.3 Provide medical support to implementation of clinical trials, including medical monitoring, medical training, and medical-related documentation review and writing.
1.4 Act as a Medical Monitor, evaluating and managing safety issues on ongoing studies. Analyze and interpret data and interact with investigators and key opinion leaders.
1.5 Provide medical insight and lead/coordinate the communication with KOLs or health authority experts for compound and/or clinical trials development.
1.6 Provide scientific support for product regulatory submission and BD collaboration.
1.7 Proactively track advancements in disease (e.g. multiple myeloma, lymphomas and leukemias as required) and therapeutic areas, policies and regulations, R&D trends, and competitor information.
1.8 Other tasks assigned by line manager.
任职资格:
2.1 Master’s degree in clinical medicine. Medical Doctor is a plus.
2.2 At least 1 year of hematology therapeutical area in clinical research in pharmaceutical or biotechnology industry.
2.3 Familiar with clinical trial regulations and guidelines.
2.4 Sound communication skills with external medical experts and/or experts in regulatory agencies.
2.5 Good English and Mandarin communication for daily work – written and oral, experience in regulatory and/or publication medical writing is preferred.