医学总监-上市前肿瘤

该职位来源于猎聘 总监或副总监级别，工作地可Base 全国 Primary Responsibilities:

• Develop product clinical development strategy and executive plan under appropriate departmental supervision.
• Establish good communication relationship with medical experts in key fields, and close communication about research programs.
• Draft, review, and QC of clinical documents to ensure compliance of documentation to GCP, SOPs.
• Development medical supervision plan and function as a medical monitor in case of need, to ensure the quality and safety of the project, including but not limited to the monitoring of SAE and programme deviation.
• Work closely with CO, RA, BD, PV and other departments, provide advice and medical support, support and assistance according to project needs (select of leading PI/ Participate in project meetings and protocol discussion).
• External communication with the sponsor or investigator.
• Provide professional proposal, exhibit experience and capabilities of FMD to clients, support bidding and make quotation.
• If necessary, support medical team in medical monitor and medical writing.
• Guide and be responsible for the quality control of the work of medical manager and senior medical specialist.
• Report the work of the medical monitor team to the medical director regularly.
• Update the SOP of medical monitor regularly.
• As a project manager for medical affairs projects, make rational timeline and ensure project progress and quality.
• Daily management and development of staff and development plan discussions.
• Contribute to the planning of and follow-up on the budget for Medical Affairs function.
• Development of company medical affairs standards and templates. Ph.D. in Medical Science, More than 3 years clinical experience in oncology or chronic disease therapeutic area.
• Or master degree major in medical science, More than 7 years clinical experience in oncology or chronic disease therapeutic area.
• Be familiar with the key points of clinical trials and relevant policies and regulations.
• Excellent ability of communication and execution, team spirit.
• Leadership, analytical, and organizational skills preferred.
• Languages: Excellent written and read English. Excellent oral English are preferred.