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按这个岗位的城市和方向提醒,确认后才开启,可选择每日或每周。
负责肿瘤药物临床研究策略制定与实施,管理项目进度、质量与费用,协调内外部专家及监管机构。要求医学博士背景、10年以上经验,具备早期肿瘤临床开发及方案撰写能力。
Key Responsibilities:
1. Formulate corresponding clinical research strategies and plans to enhance the overall clinical research level;
2. Focus on the implementation of drug clinical strategy and plan, process supervision and decision-making; be responsible for the progress, quality and expense management in the implementation process, and timely guide the solution of major issues in the process of project promotion;
3. Participate in communication and coordination with project partners, domestic and foreign clinical experts, CROs, relevant personnel of the drug administration department, etc., timely adjust project clinical strategies and plans, make the project successfully complete clinical development and meet the relevant registration requirements;
4. Work closely with the BD team to provide professional clinical assessment opinions and clinical development programs.
Requirements:
1. M.D. with relevant medical experience in Oncology area required, Physician experience is a plus;
2. More than 10 years working experience with at least five years of clinical development experience;
3. Early phase oncology development experience preferred;
4. Experience in writing clinical development protocols, IB and study reports;
5. Experience in medical and safety monitoring;
6. Fluent in written and verbal English.
Working Location: Shanghai or Beijing
科技推广和应用服务业