长沙招聘

工作职责:

Role Summary:Development China Associate Director Translational Medicine combines strong biology and disease knowledge with prior experience in clinical biomarker analysis to independently design, prioritize and successfully execute clinical translational studies that will inform key drug development decisions in the era of precision medicine.

The China Associate Director, Translational medicine may act as single point of contact to expedite study start-up and conduct and to support technical Due Diligence, biomarker assay transfer, compliance and overall study quality.

Responsibilities:Support development ideas and support/co-lead medium complexity projects. Develop and manage plans to archive objectives under appropriate supervision.

Independently design, conduct and coordinate clinical and translational research activities (medium complexity) involved in the evaluation and development of drugs within the Pfizer Oncology and non-oncology portfolio, focusing on pharmacodynamic proof-of-mechanism, patient selection/stratification and clinical proof-of-concept (POC), and underlying disease biology of relevance to combination therapy and drug sensitivity or resistance.

Independently identify, evaluate and prioritize candidate predictive biomarkers and develop clinical companion diagnostic tests (medium complexity) 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: Applies technical and disease knowledge to plan/design and conduct clinical studies focusing on integrating and executing biomarker analyses that support clinical development objectives. Develop and manage plans to archive

Scientific Excellence: Demonstrated strong biology and disease knowledge (principles, concepts and theories). Strong understanding and interpretation of biomarkers and CDx across protocols for both oncology and non-oncology studies. Interprets internal/external business challenges and best practices to recommend improvements to products, processes, or services.

Presentation and analytical skills: Demonstrate strong ability to present clinical data, study plans and tactics clearly and accurately to relevant audiences in order to obtain decision.  Make decisions that require developing innovative options to resolve complex problems.

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)

Developing Others: Will be responsible for helping to mentor less experienced Translational Medicine Scientist, and to foster continued learning within the therapeutic areas, including collection and application of lesions learned

Influencing: Be able to manage and motivate investigators and contract research organizations. Co-leads or owns the biomarker plan for a study and may influence and support medicine CDx strategy.

Innovation:  With and through others, creates an environment where innovations is the standard. Takes appropriate risk to advance innovative processes and methodologies based on comprehensive business knowledge.  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:

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 an advanced and current understanding of cancer biology, cancer genetics and immunology, and demonstrate scientific productivity (e.g. doctoral thesis, publications, research reports, etc.)

Prior Experience:

Had > 8 years industry experience demonstrating excellence 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 think strategically and creatively while contributing to multiple projects and to work well in collaborative, multi-disciplinary team setting; effective verbal and written communication skills

Demonstrate attributes of leadership at every level, encompassing characteristics of Ownit!

#LI-PFI

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。