高级医学经理

该职位来源于猎聘 工作职责：  With supervision from mentor/line manager, develop the strategic medical plan for the compound, provide medical expertise for regulatory affairs, provide medical guidance on the business plan, and lead in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc.)  Cooperate with CRO to monitor safety and efficacy data in clinical trials, and cooperate with other relevant departments to provide medical support for drug safety management  Communicate with clinical medical experts, CDE review experts and other clinical research resources to design clinical plans according to the requirements of clinical projects.  Collaborate with the study teams in the planning, startup and conduct of phase 1/3 studies. On project based, the core job responsibilities may include those listed below： Writing and/or review of critical documents like Synopsis, protocol, IB, ICF, etc. With supervision from mentor/line manager, design and review of clinical research and development plans, in line with the progress of project  With supervision from mentor/line manager, develop medical strategies, provide academic guidance and support for clinical trial projects and new drug registration Scientific Data Dissemination/Exchange  Participate in data analysis and the development of publications (abstracts, posters, manuscripts).  Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community.  Review SAEs, assess causality and expectedness of SAEs, SAE narratives, SAE reconciliation, etc.  Review of CSR, provide strategic medical guidance for the development of new oncology agents that are in preclinical development when needed. Clinical Research  Core member and scientific leader of oncology clinical development to create clinical development plan.  With supervision from mentor/line manager, design and conduct of clinical studies, and report of the study results to ensure the successful registration and commercialization of new product in China.  Work with statisticians, PV, health outcomes, research scientists and selected investigators in the development of protocols and data collection requirements.  Participate in investigator identification and selection, in conjunction with study teams. Compliance  Ensure all medical related activities follow local regulation, law, guidance and company standard and policies.任职资格：  Medical Doctorate or Master degree in clinical medicine, oncology related therapeutic area is a plus.  At least 5-8 years' experience in clinical research and development of anti-tumor drugs in pharmaceutical companies or biotechnology companies.  Be familiar with the latest progress in the field of anti-tumor, or have experience in medical supervision in the field of oncology, management of all stages of clinical research, communication with clinical researchers or cancer translational medicine, accompanying diagnosis and new drug development.  Good English listening and speaking and literature translation skills, good at English conference, communication, reading and writing; Strong communication skills and project management skills; Good copywriting skills.