岗位职责:
1. 调研创新药市场相关、产品相关进展和竞争信息;
2. 宏观政策分析和市场趋势调研支持
3. 撰写相关研究分析和发展规划报告;
任职要求:
1. 国际国内知名院校,本科学历及以上,有临床医学/基础医学/生物化学等相关专业背景,有咨询、券商研究、药企立项研究等相关实习经验者优先;
2. 具备良好的沟通、学习能力,为人踏实刻苦、勤奋上进,有较强抗压能力,对行研工作具有高度热情和自我驱动力;
3. 具有信息搜索、归纳、整理和分析能力,具备较强的逻辑思维能力;
4. 专业英语和工作英语能力强,熟悉使用MS office 软件;
语言要求:
英语、普通话
Job Summary
We are currently seeking a Lead CRA / Clinical Lead based in Shanghai or Guangzhou to join our clinical development team. This person will be responsible for providing operational expertise and leadership to ensure the effective and efficient delivery of clinical site management in our clinical trials, in cooperation with CRO vendor teams throughout the lifecycle of a study. The Lead CRA will assess clinical trial site performance (especially subject recruitment & operational quality) & adequacy of CRO monitoring activities, co-review monitoring visit reports and metrics, and proactively identify and communicate site management and monitoring issues and risks to the study team. This position offers an excellent opportunity for someone who enjoys working in a fast-paced company where he or she will have the opportunities to take ownership of his or her own work, enhance his or her current abilities and have an exciting and rewarding career in drug research and development while making a positive impact to lives of cancer patients.
Responsibilities
1)Serve as the lead of site-related clinical operations in clinical study projects, and to contribute to the accomplishment of study objectives outlined by the global clinical development plan
2)Oversee and manage CRO clinical operation teams, other third-party vendors and contractors, to ensure delegated outsourced activities are delivered according to contract
3)Contribute to the development and active management of study-specific patient recruitment strategies, keep track of study enrollment and keep in good relationship with sites
4)Collaborate with multiple study functions at CROs and vendors, including data management and EDC, drug supply chain, biostatistics, medical and pharmacovigilance, regulatory, etc.
5)Help with development of study tools, guidelines and training materials
6)Support all aspects of study management, including cost, time, quality, safety, communication, risk, vendors, stakeholders at a global scale
Qualifications
1)Bachelor or Master’s degree in scientific, biological, and life sciences
2)At least 4 years’ experience in the biopharmaceutical industry and clinical trial related activities
3)Understanding the process of drug development, with experience in global clinical operations preferred, with experience in biotech / CRO preferred
4)Knowledge and familiarity with industry standards including ICH guidelines, GCP and regulations
5)Performance driven with ability to work independently, with proven operational and tracking skills
6)Excellent organizational and priority management skills
7)Exceptional interpersonal and communication skills with conflict resolution and consensus building abilities
8)Highly collaborative and works well in a team environment, especially able to work effectively with colleagues from different
cultures, backgrounds and geographies
Language:
English、Mandarin
职责描述:
1.参与制定试验药物的临床开发战略和计划。
2.起草、审查和编辑与临床试验相关的文件,包括但不限于协议、ICF、IB、IND、MMP、SAP、DMP、DSUR、TFL、CSR和其他内部/外部材料。
3.负责监测和审查团队和CRO提供的医疗清单、编码、方案偏差、不良事件(AE)/严重不良事件(SAE)以及药物警戒活动。
4.与研究人员、专家(KOL)、临床研究团队相关人员建立和保持有效的沟通和互动。
5.咨询和培训:为跨职能团队提供科学和临床指导、专业咨询和培训。
6.分析临床数据,以供团队介绍和讨论。监督临床试验数据的分析、解释和临床试验结果的报告。
7.负责内外部会议中关于临床医学部分的演示文稿。此外,负责监管文件的临床部分(如演示文稿、摘要/海报等)。
任职要求:
1.医学院临床医学专业本科或者以上学历。
2.2-3年临床实践经验(具有执业医师证或住院医生规培证或主治医生证之一的优先)。
3.生物技术公司或制药公司或CRO公司从事临床试验医学工作(包括研究设计、方案撰写、医学监察和医学写作等等方面)三年或三年以上工作经验。
4.能够在英文环境下工作:具备优秀的医学英文阅读能力,并且可以借助AI工具完成各类医学文件的写作和中英文互译。
优先考虑条件:
1.临床肿瘤学专业或者有肿瘤临床试验经验。
2.硕士或博士学历或者第一作者发表过英文SCI学术论文发表。
3.有国际临床试验项目经验。
4.有海外留学或者工作经验。
语言要求:
英语、普通话
职责描述:
1. 负责小分子药物生物分析研究工作开展,包括生物样本LC-MS/MS方法开发、样品预处理及样品的定量分析;
2. 负责实验数据的收集整理分析,原始记录的书写、整理工作,撰写实验报告,并对研究结果进行解释;
3. 应用Winnonlin软件计算药代动力学参数。
4. 撰写、维护及升级SOP,严格按照SOP开展生物分析检测工作。
5. 负责仪器的维护,特别是LC-MS/MS的日常维护和故障诊断。
任职要求:
1. 分析化学和药学等相关专业,硕士学历,本科学历加2年以上生物分析的相关工作经验;
2. 熟练操作LC-MS/MS,熟悉仪器原理及维护,了解质谱分析原理;
3. 具有团队精神,工作认真负责,态度积极,善于沟通,有较强的学习和解决问题的能力
岗位职责:
1. 主要负责小分子化合物的纯度检测、纯化分离工作,协助解决分析分离时遇到的问题;
2. 熟练掌握药物分析基本原理,可操作质谱导向高压液相制备、中高压液相制备等分离仪器完成样品的纯化工作,并完成相应的分析检测及后处理;
3. 动手能力强,可进行相关分析仪器的维护维修工作,并通过定期保养、预防性维护等方法对分析仪器进行管理;
4. 所指派的分析、纯化工作,分析数据维护、整理及报告书写;
5. 协助完善SOP等规范化文件;
6. 协助分析分离仪器规范化管理,确保分析分离工作顺利进行。
任职要求:
1. 本科及以上学历,五年以上相关工作经验。
2. 热爱分析分离及药物研究工作,熟悉HPLC、LCMS、NMR等分析仪器的维护操作及排障维修,有岛津、安捷伦LCMS使用经验者优先;
3. 熟悉多种样品前处理方法,能解决多组分分离方面问题,有分析方法开发经验,具有独立开发检测方法的能力;
4. 责任心强,富有团队协作精神;
良好的沟通能力和问题分析解决能力。
申请该职位
工作职责:
负责欧美的BD业务,
1. 欧美BD项目源开拓、项目对接,筛选评估谈判;
2. 协助欧美BD开展,项目对接,初步评估,交易谈判;
3. 协助整理项目资料,信息搜集,熟悉行业,有项目源,能协助谈判。
任职要求:
1. 硕士以上学历,生物、化学、药学、医学等生物医药相关专业;
2. 5年以上BD经验,拥有顶级公司的生命科学/医疗领域的战略咨询、跨国业务拓展或投资银行经验优先;
3. 了解尽职调查、资产评估、联盟整合和投资组合管理的过程,结合科学和商业头脑;
4. 具有良好的组织和人际交往能力,沟通能力强,有良好的谈判和交易谈判能力,在压力下能保持冷静;
5. 流利的英语听说读写能力。