Preclinical Project Manager

5 days ago

Shanghai, Shanghai, China 上海英方软件股份有限公司 Full time

该职位来源于猎聘 Responsibility: 1. 负责与前期研发部门(包括平台技术、药物发现、药理药效研究等)的沟通协调,全面跟踪项目的研发进展,定期汇总并汇报项目状态。 Be responsible for communication and coordination with early-stage R&D departments, comprehensively tracking project development progress, and regularly consolidating and reporting project status. 2. 协调CMC部门进行临床前研究所需样品的制备、质量控制和供应计划,确保药理、药代及毒理试验的顺利启动与开展。 Coordinate with the CMC department for the preparation, quality control, and supply planning of samples required for preclinical studies, ensuring the smooth initiation and execution of pharmacology, pharmacokinetics, and toxicology experiments. 3. 根据具体项目的科学目标和技术特点,主导筛选并评估外部合作单位(如CRO)的资质与能力;在试验执行期间,作为主要联络人,与项目承担方保持紧密沟通,及时发现并协助解决实验过程中的技术难点与挑战。 Lead the screening and evaluation of external partners' (e.g., CROs) qualifications and capabilities based on the specific scientific objectives and technical characteristics of the project. Serve as the primary liaison during study execution, maintaining close communication to promptly identify and assist in resolving technical challenges encountered during experiments. 4. 负责审查项目承担单位提供的试验原始记录、数据及报告,确保其真实性、完整性和规范性,符合GLP等质量管理要求。 Be responsible for reviewing the original experimental records, data, and reports provided by project contractors, ensuring their authenticity, integrity, and compliance with quality management standards such as GLP. 5. 密切跟进项目的整体进展,精准把握关键里程碑和时间节点,有效管理项目预算,识别潜在风险并及时提出调整方案。 Closely monitor the overall project progress, accurately manage key milestones and timelines, effectively control the project budget, identify potential risks, and propose timely adjustments. 6. 组织并参与项目相关会议,撰写项目进展报告、总结报告等文档,为内部决策和 注册申报提供支持。 Organize and participate in project-related meetings; prepare project progress reports, summary reports, and other documentation to support internal decision-making and regulatory submissions. Requirements: 1. 药理学、毒理学、生物学、生物化学或相关生物医药专业,硕士或以上学历。 Master's degree or higher in Pharmacology, Toxicology, Biology, Biochemistry, or related biomedical fields. 2. 6年及以上在制药企业或CRO公司从事药物临床前研发或项目管理相关工作的经验,具有创新药项目经验者优先。 Minimum of 6 years of relevant experience in preclinical drug R&D within pharmaceutical companies or CROs. Experience with innovative drug projects is preferred. 3. 具备丰富的项目管理经验和卓越的跨部门、跨组织协调能力,能够高效整合资源。擅长分析和解决复杂问题,并具备出色的应急预案制定与风险管理能力。 Substantial project management experience and excellent cross-departmental and cross-organizational coordination skills, with the ability to efficiently integrate resources. Proficient in analyzing and solving complex problems, with strong capabilities in contingency planning and risk management. 4. 深入了解药物临床前研发的全流程,包括药效学、药代动力学、毒理学评价以及IND申报的相关知识与法规要求。 In-depth understanding of the entire drug preclinical R&D process, including pharmacodynamics, pharmacokinetics, toxicology evaluation, and relevant knowledge/regulations pertaining to IND submissions. 5. 英语听说读写能力流畅;能独立检索和阅读英文专业文献,熟练撰写各类专业报告和技术文件。 Fluent in English listening; able to independently search and review English professional literature and skillfully prepare various professional reports and technical documents.

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