上海和记黄埔医药
上海 ·医疗卫生 ·100-499人
Clinical Biomarker AD (CDx)
30-50K
上海
5-10年
硕士
全职
职位描述
Responsibilities：
• Design and execute companion diagnostic development strategy for oncology programs.
• Closely follow industry and regulatory trends related to companion diagnostic product development.
• Work closely with cross-functional teams to design and execute biomarker-driven clinical trials.
• Lead the development and validation of biomarker assays for clinical use, including proficiency testing, analytical validation, and clinical validation.
• Contact and oversee diagnostic reagent companies with central lab service and CDx development service capabilities
• Participate in the preparation of regulatory submissions related to biomarkers and the communication with regulatory authorities.
• Evaluate new technologies to implement in clinical studies to address emerging biomarker questions.
Qualifications：
• Ph.D or MD in molecular biology, or related discipline with 5+ years of industrial experience working in translational research or IVD/CDx development.
• Strong knowledge of various biomarker platforms (such as IHC, flow cytometry, NGS, Luminex, QPCR, etc.) and their clinical practice.
• Experience of companion diagnostic development and assays validation in drug development is preferred.
• Ability to multitask across multiple development assets and to work in a fast-paced, dynamic environment. Work in a flexible schedule to meet deadlines.
• Proven ability to frame issues, ask the right clarifying questions, and rationalize decisions.
• Good interpersonal and coordination skills.
• Good written and oral language skills in English and Mandarin Chinese
• Design and execute companion diagnostic development strategy for oncology programs.
• Closely follow industry and regulatory trends related to companion diagnostic product development.
• Work closely with cross-functional teams to design and execute biomarker-driven clinical trials.
• Lead the development and validation of biomarker assays for clinical use, including proficiency testing, analytical validation, and clinical validation.
• Contact and oversee diagnostic reagent companies with central lab service and CDx development service capabilities
• Participate in the preparation of regulatory submissions related to biomarkers and the communication with regulatory authorities.
• Evaluate new technologies to implement in clinical studies to address emerging biomarker questions.
Qualifications：
• Ph.D or MD in molecular biology, or related discipline with 5+ years of industrial experience working in translational research or IVD/CDx development.
• Strong knowledge of various biomarker platforms (such as IHC, flow cytometry, NGS, Luminex, QPCR, etc.) and their clinical practice.
• Experience of companion diagnostic development and assays validation in drug development is preferred.
• Ability to multitask across multiple development assets and to work in a fast-paced, dynamic environment. Work in a flexible schedule to meet deadlines.
• Proven ability to frame issues, ask the right clarifying questions, and rationalize decisions.
• Good interpersonal and coordination skills.
• Good written and oral language skills in English and Mandarin Chinese
公司介绍
和黄医药的目标是成为一家为中国和全球市场开发创新药物的领先的医药公司。我们诚邀有志人士加入我们的团队。我们致力于让每一名员工能够发挥才干，并提供互相协作的工作环境以回报您的才能和热情。如果您希望成为我们团队的一员，请将您的简历发送给我们
上海浦东新区国家生物医药基地4
面试经验
