北京招聘

Job Purpose

State the overall objective of the position Design, monitor and review reports of the studies on biomarkers developed for clinical trials and as companion tests for clinical use, and additional tasks assigned by the preclinical management

Major Accountabilities

1. Plan, budget, oversee and document all aspects of the biomarker projects. And work closely with upper management to make sure that the scope and direction of each project is on schedule
2. Discovering and validating the new biomarkers using cell biology molecular biology, animal models and clinical samples to provide a scientific basis for drug development
3. Understand and clarify the mechanism of action for the candidate drugs and the sensitivity /specificity of biomarkers
4. Participate in biomarker development strategy discussion and decision- making. Draft the study synopsis based on the preclinical and clinical information and development plan
5. Working with contract research organization (CRO) on drafting and finalizing contracts, protocols, reports, etc. Responsible for the protocols and reports reviewing and approval once confirmed by preclinical management, and secure the supplies of the biomarker kits and related reagents for clinical use
6. Take the lead in discussing and resolving issues with CROs or partners and follow up the results when finding inappropriate actions, data or any other issues, and ensure the meeting minutes of any decision, problem solving and critical issue be timely recorded and retained
7. Working with Medical affairs to assess clinical values and determine the cut off values of biomarkers
8. Working with Clinical Operation to provide technical support to ensure the biomarker tests are correctly conducted and used in the clinical trials

北海康成（北京）医药科技有限公司正式成立于2012年6月，总部设立在中关村望京科技创业园区内。
北海康成致力于解决满足“三个需求”，即满足中国患者对高效药物的需求、中国药企关键技术、产品更新换代的需求、发达国家中小生物制药企业进入中国市场的需求。
北海康成通过技术转让、吸收和再创新对接世界最大的生命高科技医药产品线与全球增长最快、潜力最大的应用市场。公司引进、研发、上市的重点是中国和亚洲市场所急需的特效药物。北海康成已经与欧美创新型生物制药公司、研究机构开展多个抗癌药物领域的技术合作。公司注重临床后期新药开发，有针对性地获取尖端的或国内新药研发所急需的制剂和生产工艺方面的成果，通过再创新和技术转化研发上市拥有自主知识产权的医药产品。