苏州招聘

职位描述：
1、 Education：√Doctor√Master
2、 Experience：At least 3 years of clinical research experience and at least 2 years of clinical project management experience; Global trial experience is preferred
3、 Language Skills：English is working language
4、 professional knowledge& Skills：Education background is life science related and medical training is preferred; Project management certification is preferred
5、other requirements: Be able to manage long term oversea travel

 position statement
1、Project Administration - Acts as a primary liaison between the Company and the Customer to ensure study launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
2、Coordinates project organization, implementation, and management activities between all Company operations and the client. Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Oversees and tracks site payment issues as required. Alerts Finance on the need for Customer invoicing.
3、Oversees the regulatory document collection and submission process. Ensures project documentation, including Trial Master Files are complete and audit ready.
Assists in the negotiation and contracting process with outside vendors (labs, printers, etc). May perform or oversee site feasibility assessments. Develops and maintains project plans for the study in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WI).
4、Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports, and functional area plan to appropriate team members and senior management. Performs ongoing review of project financial status of studies. Alerts senior management to potential issues and ensures necessary corrective action is taken.
5、Communication – Be able to prepare and present study material at client meetings and communicates outcomes to project team at review meetings. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans. 举报 分享

关于天演：

天演药业是一家以“天下没有难做的抗体”为使命，致力于打造拥有自主知识产权的“动态精准抗体库”和独特原创抗体产品线的临床阶段的生物药企。天演基于原创的技术平台，深度布局肿瘤免疫及靶向治疗领域，以靶点及抗体技术创新为驱动，以充分的转化医学数据为依据，力争实现产品在临床疗效及安全性等方面的突破。
基于天演自己的核心平台技术，公司在肿瘤免疫及靶向治疗领域建立了丰富的横跨特异表位抗体，多特异抗体，及安全抗体为代表的创新抗体产品系列。公司自主研发的激动型全人源单克隆抗体ADG106目前已在美国和中国同时进行I期临床爬坡试验。该药物的独特靶位及作用机制属于全球首创，在药效及安全性的临床前优异表现可望在充满挑战的激动性抗体的研发上另辟蹊径，从而满足尚未满足的肿瘤免疫治疗的临床需求。未来天演药业将有更多产品陆续进入临床试验。
天演药业已完成三轮融资，累计募资超5亿元人民币。投资人包括F-Prime资本（原富达波士顿生物科技基金），斯道资本风险投资（前富达成长基金）、药明康德风险投资基金、金浦健康基金和新世界信息科技以及红杉中国。
公司成立七年多来，已获得国家科技型中小企业、技术先进型服务企业，园区独角兽培育企业等多项荣誉。

About Adagene

Adagene (Suzhou, China and San Francisco, California) is a clinical stage biotech company with innovative antibody discovery and engineering technologies，by utilizing its proprietary Dynamic Precision Library Platform (DPL).
Adagene is showcasing its exceptional antibody engineering capabilities by building franchises of products with multi-specific antibodies that are cross-species reactive enabling easy and accurate identify pre-clinical POC and safety study in animal models. Also, Adagene is developing a third-generation technology, SAFEbody? to enhance the therapeutic window for antibodies.
Adagene’s lead product has been approved by FDA and NMPA to enter human clinical study in advanced solid tumors and non-Hodgkin lymphoma patients and has successfully finished first patient dosing in September 2018 in US, with Adagene’s second and third products anticipate filing global INDs in 2019 and 2020.
The company's management team is composed of industry veterans with proven track record in therapeutic antibody R&D. Adagene is backed by top notch global venture funds such as F-Prime Capital Partners, Eight Roads Ventures, Wuxi Pharmatech Healthcare Fund I L.P., GP Healthcare Capital, New World TMT Ltd and Sequoia China. The company has raised over $85 million through its series A to C financing.