EG-Translational Medicine Scientist(J17610)社
面议
市辖区本科及以上2年及以上
发布时间:2023-09-06
职位描述
工作职责:
Development China Translational Medicine Scientist combines the understanding of disease biology with prior experience in clinical trial sample analyses to successfully execute clinical translational studies that will inform key drug development decisions in the era of precision medicine.The China Translational medicine scientist may act as point of contact to expedite study start-up and conduct and to support biomarker assay transfer, compliance and overall study quality.
Responsibilities:
Conduct and coordinate clinical and translational research activities involved in the evaluation and development of drugs within the Pfizer Oncology and non-oncology portfolio, focusing on pharmacodynamic proof-of-mechanism/pharmacology, patient selection/stratification and clinical proof-of-concept (POC), and underlying disease biology of relevance to combination therapy and drug sensitivity or resistance.
Identify and evaluate candidate predictive biomarkers and develop clinical companion diagnostic tests that will appropriately transition from early to late phase clinical development.
Work directly with a variety of external contract research organizations/vendors as well as academic collaborators and key opinion leaders to execute and expand clinical translational research efforts.
Work collaboratively within highly integrated, multi-functional program teams that includes scientists within Discovery Research, Research Precision Medicine, Computational Biology, Clinical Pharmacology and Development Operations groups, as well as Clinicians, Statisticians, and Asset Team Leads.
Technical / Behavioral Competencies:
Technical Competencies
Clinical Project Expertise: demonstrated potential or ability to initiate and conduct clinical studies focusing on integrating and executing biomarker analyses that support clinical development objectives
Scientific Excellence: demonstrated understanding of pre-clinical and clinical disease biology, and the ability to apply that knowledge to drug development; demonstrated understanding of the complexities and recent developments in the relevant therapeutic/technical area, and the ability to apply such knowledge to drug development
Presentation and Analytical Skills: demonstrates ability to present clinical data, study plans and tactics clearly and accurately to relevant audiences in order to obtain decision
Behavioral Competencies
Networking and Alliance Building: Able to work across many interfaces: clinical-regulatory; clinical-marketing; clinical-project management; clinical-development operations (biometrics, monitoring resource, study reporting)
Influencing: be able to manage and motivate investigators and contract research organizations
Innovation: Constantly challenge existing paradigms in clinical research and encourage breakthrough designs; work with clinical development operations on study design, data capture and retrieval, reporting
Courage with decisiveness to Act: Bias towards action to achieving goals
Conflict Management: Good at focused listening; can find common ground and get cooperation with minimum noise
任职资格:
Qualifications (Training, Education & Prior Experience):
Education:
Preferred PhD, MD, MD/PhD, Pharm. D or equivalent qualifications. Postgraduate training/certification /fellowship in a medical discipline or in drug development with focus on disease biology and biomarkers. Candidates should possess understanding of cancer biology, cancer genetics and immunology, and demonstrate scientific productivity (e.g. doctoral thesis, publications, research reports, etc.)
Prior Experience:
Had industry experience in designing, executing and interpreting studies of cancer biomarkers in clinical trials, including biomarker development, validation and clinical application; familiarity with clinical trial design, logistics and regulatory issues; familiarity with the development and regulatory approval of oncology companion diagnostics.
Demonstrated ability to work well in collaborative, multi-disciplinary team setting; effective verbal and written communication skills
其他要求
-
1人
公司介绍
On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外,该中心是辉瑞全球安全和风险管理部的一个分支,负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。
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