上海招聘

Major Responsibilities             

• Participates in clinical trial scenario planning (estimates timeline and cost, requests internal resources)
• Works with Strategic resourcing team to select study vendors
• Oversees study vendors to ensure quality and delivery
• Oversees the development of and adherence to clinical trial project timelines
• Ensures senior Clinical Operation staff, DCT, and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
• Coordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection) with other BeiGene functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
• Ensures study plans (including but not limited to project plan, communication plan, issue escalation plan, clinical monitoring plan, medical monitoring plan, drug safety monitoring plan, data monitoring plan, Trial Master File plan and etc) are created, updated and distributed timely
• Coordinates with Clinical Supply Chain regarding drug forecasting and supply of drug products to sites
• Ensures site monitoring reports are accurate and reviewed on a regular basis
• Closely monitors Case Report Form (CRF) data entry and source document verification (SDV) status
• Ensures that Trial Master File (TMF) for assigned clinical trial(s) is created, maintained, QC checked and complete on a timely basis
• Reviews trial scope, budget and change orders. Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecast
• Adheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs, if required

• Bachelors degree or higher in a scientific or healthcare discipline preferred
• 5 years or above of progressive experience in clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
• Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required
• Management experience of CROs and other Vendors preferred
• Therapeutic or medical knowledge preferred
• Experience developing trial plans including project plan, site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required. 
• Exhibits a strong understanding of methodologies and approaches
• Strong written and verbal communication skills

百济神州是一家植根中国的全球性商业化生物医药公司，致力于成为分子靶向药物和免疫肿瘤药物研发，及商业创新领域的全球领导者。
2017年，百济神州与新基公司达成战略合作伙伴关系，向新基转让了tislelizumab在美国、欧洲、日本和亚洲以外的其他地区的实体瘤开发和商业化的独家权益，保留了在亚洲（除日本外）开发和商业化tislelizumab用于治疗实体瘤的权益，以及用于治疗恶性血液肿瘤和进行内部组合疗法的全球范围权益。

此外，百济神州获得了新基公司在华获批药物——注射用白蛋白紫杉醇（ABRAXANE？）, 瑞复美（REVLIMID？）和 维达莎（VIDAZA？）的独家授权，并接管其在华商业运营团队。

2018年1月，百济与Mirati公司sitravatinib在亚太地区的独家授权协议，进一步拓宽了公司的产品组合。

截至目前，百济神州在全球各地拥有超过1100名员工，其中包括在中国、美国、澳大利亚和瑞士的超过650名科学家及临床医学专家。

公司在中国的北京、上海、美国的马萨诸塞州Cambridge，新泽西州Fort Lee和加利福尼亚州旧金山Emeryville和San Mateo，瑞士的巴塞尔均设有办事机构。除此之外，百济神州在中国大陆还拥有位于北京的研发中心，苏州、广州两大生产基地，以及在上海的商业运营中心。