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Companion Diagnostics (CDx) Lead ID172963
3-5万
人 · 硕士 · 1年及以上工作经验 · 性别不限2024/10/08发布

上海市

公司信息
勃林格殷格翰(中国)投资有限公司

外资(欧美)/10000人以上

该公司所有职位
职位描述
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.

Job Requirements
- As Companion Diagnostics (CDx) Lead, Translational Medicine & Clinical Pharmacology(TMCP) China you will be accountable for the successful implementation of CDx in drug development programs in China.
- You will support local and global project teams for successful CDx test development in China including (early) clinical, registrational and operational aspects.
- You will represent Boehringer in Joint Project teams between Boehringer and external CDx partners.
- You will coordinate and manage CDx development and registration activities at the CDx partner/ Boehringer interface to ensure timely submission of drug and CDx test.
- You represent the respective area of responsibility in meetings, local and global decision-making committees, and provide advice and support through Boehringer07s CDx Center.
- Your responsibilities also include supporting the qualification and management of third-party laboratories and IVD partners, and contributing to CDx-related issues in early and late stages of in-licensing opportunities.
- You will monitor the external CDx landscape with regard to new opportunities, technologies and trends as well as changes in legislation.
- You will manage the personnel in TMCP China team to support TMCP global functional goals in alignment with Boehringer China07s internal people policy.
- Ensure a solid talent pipeline of key positions for TMCP China. Developing, supporting and encouraging a learning culture.

Requirements:
- Medical degree or PhD in Life Sciences, preferably with a focus on Precision Medicine/ Companion Diagnostics (CDx).
- Extensive experience in Precision Medicine, CDx, and clinical drug development.
- Deep understanding of applicable regulatory requirements with focus on China.
- Strong disease-area knowledge, particularly in Oncology, with a comprehensive scientific knowledge of the pathophysiology and therapeutic modalities currently approved or in clinical development.
- Personal track record in implementing biomarkers / CDx assays in drug development and a clear understanding of the clinical application of such markers, their evaluation and analysis, and the linkage between the biomarker and clinical endpoints.
- Excellent communication and negotiation skills with the ability to work effectively in a matrix environment.
- People management and group development skills is a good plus.
- Ability to communicate effectively in both Mandarin and English through reading, writing, and speaking.

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