LTD/TOX-毒理商务中心项目经理

Responsibilities The Project Manager will primarily support and manage clients’ IND (Investigational New Drug) programs and oversee drug development progress in both the U.S. and China. He/She will work closely with project teams and scientists at WuXi’s Suzhou, Nantong, and other sites. Key Responsibilities: • Work independently or under supervision in a highly motivated project management team and dynamic environment. • Provide technical support during the business development phase, including but not limited to: understanding IND submission requirements of the U.S., China, and EMA; evaluating clients’ development programs; and preparing project proposals and preliminary study designs based on compound characteristics, clinical indications, intended clinical trial plans, existing data, and target submission regions. • Lead and manage the nonclinical portion of IND-enabling programs: develop program execution plans (Gantt charts), monitor program progress across pharmacology, DMPK/ADME, toxicology, bioanalysis, and regulatory submission activities; host regular project meetings to review status, study results, issues, and resolutions; and coordinate with other divisions for extended IND programs when needed. • Provide continuous scientific and technical support during program execution, proactively identify potential issues, and propose constructive solutions. • Maintain timely communication with clients and key internal contributors across functions/business units via email, teleconferences, Zoom meetings, and/or site visits to ensure smooth program execution. • Track relevant scientific advances by reviewing literature and share updates with the team and business units. 岗位职责 项目经理将主要支持和管理客户的 IND（新药临床试验申请）项目，并跟进中、美的分子药物开发进展。他/她将与公司的苏州和南通等项目团队和科学家紧密合作。 主要工作内容： • 在高度积极的项目管理团队和充满活力的环境中，能够独立或在指导下开展工作。 • 在业务开发阶段提供技术支持，包括但不限于理解美国、中国、欧洲药监局 (EMA) 等监管机构的 IND 申报要求；评估客户的研发项目；基于化合物特性、临床适应症、预期临床试验方案、既有研究数据以及申报目标区域等，制定项目建议书和初步研究设计。 • 领导和管理 IND 支持性非临床项目：制定项目执行计划（甘特图），监督项目执行，包括药理、DMPK/ADME、毒理学、生物分析等研究直至递交申报；定期主持项目会议，更新/讨论项目进展、研究结果/问题及解决方案；必要时协调公司其他部门参与拓展性的 IND 项目。 • 在项目执行阶段，持续提供科学和技术支持，主动识别潜在问题并提出建设性建议。 • 与客户以及公司各职能/业务单元的关键项目人员进行及时沟通，通过邮件、电话会议、Zoom 会议及现场访问等方式，促进项目顺利推进。 • 关注相关科学进展，检索和评阅科学文献，并向团队和业务单元提供更新。