85 Combine medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., oncology biomarkers and imaging, clinical pharmacology, biostatistics, etc.) to optimize the clinical development plan.
85 Work with senior managers to drive the strategic medical plan for the compound, provide medical expertise for regulatory affairs, providing medical guidance on the business plan, and local scientific data dissemination （presenting at conferences, advisory boards, etc.)
85 Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring)
85 Monitor safety and efficacy data in clinical trials, and cooperate with other relevant departments to provide medical support for drug safety management.
85 Communicate with clinical medical experts, CDE review experts and other clinical research resources to design clinical plans according to the requirements of clinical projects.
85 Collaborate with the study teams in the planning, startup and conduct of phase 1 to 3 studies. On project based, the core job responsibilities may include those listed below：
89 Writing and/or review of critical documents like study synopsis, protocol, IB, ICF, etc.
89 Design and review of clinical research and development plans, in line with the progress of project.
89 Develop medical strategies, providing medical guidance and support for clinical trial projects and new drug registration.
89 Scientific Data Dissemination/Exchange.
89 Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
89 Participate in data analysis and the development of publications (abstracts, posters, manuscripts).
89 Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community.
89 Review SAEs, assess causality and expectedness of SAEs, SAE narratives, SAE reconciliation, etc.
89 Review of CSR, provide strategic medical guidance for the development of new oncology agents that are in preclinical development when needed.
85 Responsible for the implementation of medical-related strategies for post-market products.
85 Collaborate with internal and external stakeholders and provide medical support.
85 Ensure all medical related activities are in compliance with local regulation, law, guidance and company standard and policies.
任职资格：
89 Medical Doctorate degree or M.Sc in clinical medicine, oncology/hematology related therapeutic area is a plus.
89 Have 2~5 years' medical monitoring experience for innovative oncology drug in CRO/pharmaceutical companies.
89 Good English listening and speaking and literature translation skills, good at English conference, communication, reading and writing.
89 Strong communication skills and project management skills. Good copywriting skills.
