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该职位负责确保生物标志物策略与临床运营计划保持一致,评估生物标志物研究提案,确定研究程序,审核知情同意书和人体生物样本管理。担任外部供应商的主要联系人,监督供应商实验室的生物标志物检测开发,领导数据分析并评估新技术。
Responsibilities:
• Ensure alignment of biomarker strategies with clinical operational plans.
• Ensure successful implementation of biomarker strategies including assessment of biomarker research proposals, study procedure determination to ensure accurate and appropriate sample collection, consent forms and Human Biological Sample Management review to ensure its alignment with the protocol, data standards determination to ensure appropriate biomarker analysis, etc..
• Serve as a key contact for external vendors and oversee biomarker assay development at vendor labs.
• Lead the analyses of biomarker data, collaborating with statisticians, bio-informatics clinical and translational groups.
• Evaluate new technologies to implement in clinical studies to address emerging biomarker questions.
Qualifications:
• Candidate should have a Master or Ph.D. degree in biology, pharmacology or a related field. 1-3 year clinical biomarker experience in pharmaceutical or CRO companies is highly desired.
• Demonstrated knowledge of oncology and/or immunology disease biology, and various biomarker platforms (such as IHC, FACS, FISH, NGS, ELISA, etc.) and their clinical practice.
• Good interpersonal skills for building relationships across functions internally and externally. Effective collaboration with colleagues and partners.
• Strong aspiration for drug discovery work, diligent, self-motivated, independent, strong sense of responsibility.
科技推广和应用服务业
该职位负责公司临床项目组合的管理,推动项目定义、优先级排序、监控和资源分配。提供项目组合进展的定期沟通,与跨部门项目发起人合作确保数据完整性。负责项目组合预算管理,指导项目经理,营造高绩效团队环境。