大连招聘

1. Direct the development of clinical strategies and plans to integrate Alvotech & CCHN’s molecules into the standard practice of autoimmune and oncology diseases.

主导公司临床项目战略和开发计划，以将Alvotech＆CCHN的分子整合到自身免疫和肿瘤疾病的标准实践中

2. Responsible for evaluating and screening PI, CRO and clinical trial bases, leading the various processes of clinical operations

负责评估、筛选PI、CRO及临床试验基地，主导临床研究的各个过程；  

3. Fully responsible for the management of clinical trials (mainly Phase I ~ IV clinical trials) of company projects, including planning, execution, supervision, inspection, risk control, etc.

全面负责公司项目的临床试验（主要是I期~Ⅳ期临床试验）管理工作，包括计划、执行、监督、检查及风险控制等等

4. Ensure that the clinical project operation meets the requirements of ICH, GCP, SOP and local laws and regulations, and that the project can respond to the requirements raised during the audit and verification process at any time during the operation

保证临床项目运行中符合ICH,GCP，SOP及地方法律法规的要求，保证项目在运行中可以随时应对稽查，核查过程中提出的要求

5. Responsible for the organization, review and filing of clinical trial data

负责组织临床试验资料的整理、审核与归档；

6. Responsible for organizing the writing of application documents for clinical part

负责组织有关临床申报资料的撰写；

7. Gradually establish a clinical team, guide and train team members

逐步建立临床团队，指导和培养团队成员；

 

岗位要求：

· MD degree or above with immunology or oncology training preferred

· 8+ years’ experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs

· Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical operations

· A proven success record in Phase I-IV clinical research studies and trial designs as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s and MAA’s)

· Familiar with Chinese clinical trial regulations, familiar with FDA, EMA clinical trial regulations is preferred

· Fluent in written and oral English is required

长春安沃高新生物制药有限公司成立于2019年3月,注册资本为2亿美元，坐落在长春市高新北区北湖开发区，是由长春高新技术产业（集团）股份有限公司与冰岛Alvotech.Hf（安沃泰克）合资建立的集靶向抗体药物研发、生产、销售于一体的高新技术企业,公司引进的6个品种均属于“重磅***”级别，2018年的销售额均超过20亿美元，其中阿达木单抗连续6年蝉联全球药王之位，2018年的销售额近200亿美元。公司2019年开始施工建设，建设周期2-3年，预计2022年***款产品上市，五年内实现两个产品上市，4个产品进入临床，同时适时启动公司的IPO。到2030年，估计营业收入可达60亿元、净利润15亿元、税金5亿元。
Changchun Alvotech &CCHN Bio-Pharmaceutical Co,Ltd.was founded in March 2019 by Alvotech Hf and Changchun High-tech Industry (Group) Co,Ltd, which had a registered capital of US $200 million. The company is located in Changchun Beihu Science and Technology Development Zone, China. Changchun Alvotech &CCHN Bio-Pharmaceutical Co,Ltd.is engaged in the research and development, production, sales in one of the high-tech JV.The six varieties introduced by Alvotech & CCHN all belong to the “ heavy bomb” class, with sales of more than $2 billion in 2018, of which adalimumab has been the world drug king for 6 consecutive years, with the sales of nearly $20 billion in 2018.Construction began in 2019, with a construction period of 2-3 years. Alvotech & CCHN's first product will be on the market in 2022, two products will be launched in the next five year, and the remaining four products will be in the clinical research stage. At the same time, company's IPO will be launched. By the 2030, it is conservatively estimated that revenue will reach to 6 billion RMB, net profit will be 1.5 billion RMB, and tax will be 500 million RMB.