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(Sr.) Manager, Translational Medicine/Biomarker Management

(2021-11-12)

第一三共(中国)投资有限公司

职位性质:  全职 工作经验:  不限 招聘人数:  1 工作地点:  上海
学历要求:  不限 语言要求:  不限 简历要求:  中文 薪资待遇:  面议

职位关键字:

Specific Responsibilities:

Lead Translational Medicine activities in China

1.Develop and support local translational biomarker strategy aligned with global strategy

2.Provide the technical inputs in terms of China HGRAC regulation and local practice to Translational Translational Lead and Clinical Biomarker Lead in the evaluation and development of clinical biomarker assays and testing sites for early and late stage oncology projects in China

3.Provide relevant area expertise for improving the quality of biomarker testing to support early and late phase clinical development in China

4.Contribute to the development, preparation  and execution of biomarker assays for clinical development for future new study setup in China, including: 1) identify appropriate biomarker tests, technology solutions, sample processing, and lab testing vendor and specialty labs for Cancer Enterprise clinical trials and programs; 2) provide input on biomarker related sections of clinical study protocols including the necessary sample collection, processing and shipping requirements.; 3) manage clinical sample analysis at analytical vendors; 4) execute clinical sample tracking and reconciliation about sample information collaborating with SM/SA; 5) archive essential documents related to test validation and biomarker clinical study reports.

5.Support scientific & technical communication with China sites on biomarker testing and engage sponsor clinical experts when needed.

6.Work as liaison to communicate with translation medicine function on individual study – local lab solution and vendor inspection, CDx China status update, Attend global clinical biomarker monthly meeting and contribute to global biomarker analysis project progress report

7.Be involved in the sample analysis data review to present the result to and engage Chinese investigators

8.As coordinator in China to collaborate with IVD vendor on CDx testing and associated regulatory submissions

9.Participate in the evaluation of advanced technologies for IVD and clinical biomarker development for suitability in Chinese market

10.Lead TM/BM related trainings to DS internal stakeholders


Experience and Qualifications:

1.Master Degree and above majored in Medicine, Pharmacy, Biological Science or related.

2.Five years or above in foreign-funded Clinical Department in Medicine and Pharmaceutical Industry, rich experience in clinical sample management in China.

3.Fluent English listening, speaking, reading and writing skills

4.Strong leadership in interacting with multiple internal and external stakeholders and team management 

5.Excellent communication skill in both Chinese and English

6.Excellent skill in critical thinking and problem solving

7.Strong team player

8.Integrity and high ethical standards

9.Good command of Computer


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