Biomarker SD/D/AD(J25973)当面告知
信达生物制药(苏州)有限公司
2026-11-13 00:00:00
社招博士本科
岗位详情
地区:
上海市
·
苏州市
专业要求:
生物制药生物医学生物医药数据科学
岗位职责:
Purpose of the Job
This role will be responsible for leading the development and implementation of biomarker and CDx strategies in support of our innovative pipeline. The leader will play a crucial role in driving the discovery, selection, validation, and clinical application of biomarker and CDx assays, working closely with cross-functional product development teams to advance our pipeline and deliver breakthrough therapies to patients in need.
Main Duties
1. Responsible for the formulation and implementation of biomarker and drug effect kinetic strategies. Including planning and coordinating the collection and distribution of samples for early and late clinical trials.
2. Responsible for formulating and implementing biomarker operation management specifications, including Human Genetics Office management, supplier management, and internal management to ensure project quality, efficiency, and compliance with regulations; complete and monitor research budgets and financial transactions with suppliers.
3. Responsible for developing CDx strategies to align with clinical development program budgets and ensure successful implementation of companion diagnostic assays in clinical trials.
4. Work closely with internal and external teams to ensure timely completion of project plans and delivery of results.
5. Interact and cooperate with external diagnostic providers and global regulatory agencies (China, the United States and other regions around the world) to establish CDx filing pathways and strategies to ensure compliance with regulatory requirements.
Education:
PhD degree;biology, translational medicine and other life science related major.
Professional Knowledge:
Extensive knowledge of established and novel diagnostic technologies, relevant regulations in China and other countries, and understand the drug development process and biomarker applications.
Work Experience:
1. More than 8 years of relevant experience in translational medicine.
2. Have extensive experience in the field of oncology area. Familiarity with target/disease biology, preclinical and clinical development.
Skill Requirement:
1. Excellent organizational communication and coordination skills.
2. Excellent spoken and written English skills
Other Requirements:Good interpersonal and ownership.
招聘要求:
Purpose of the Job
This role will be responsible for leading the development and implementation of biomarker and CDx strategies in support of our innovative pipeline. The leader will play a crucial role in driving the discovery, selection, validation, and clinical application of biomarker and CDx assays, working closely with cross-functional product development teams to advance our pipeline and deliver breakthrough therapies to patients in need.
Main Duties
1. Responsible for the formulation and implementation of biomarker and drug effect kinetic strategies. Including planning and coordinating the collection and distribution of samples for early and late clinical trials.
2. Responsible for formulating and implementing biomarker operation management specifications, including Human Genetics Office management, supplier management, and internal management to ensure project quality, efficiency, and compliance with regulations; complete and monitor research budgets and financial transactions with suppliers.
3. Responsible for developing CDx strategies to align with clinical development program budgets and ensure successful implementation of companion diagnostic assays in clinical trials.
4. Work closely with internal and external teams to ensure timely completion of project plans and delivery of results.
5. Interact and cooperate with external diagnostic providers and global regulatory agencies (China, the United States and other regions around the world) to establish CDx filing pathways and strategies to ensure compliance with regulatory requirements.
Education:
PhD degree;biology, translational medicine and other life science related major.
Professional Knowledge:
Extensive knowledge of established and novel diagnostic technologies, relevant regulations in China and other countries, and understand the drug development process and biomarker applications.
Work Experience:
1. More than 8 years of relevant experience in translational medicine.
2. Have extensive experience in the field of oncology area. Familiarity with target/disease biology, preclinical and clinical development.
Skill Requirement:
1. Excellent organizational communication and coordination skills.
2. Excellent spoken and written English skills
Other Requirements:Good interpersonal and ownership.
公司介绍
信
信达生物制药(苏州)有限公司
信达生物制药(苏州)有限公司,成立于2011-08-24,位于江苏,法定代表人:旦巧荣,登记状态:存续,注册资本15946.475万美元,公司类型:外企独资
公司信息:公司名称:信达生物制药(苏州)有限公司公司类型:制药/生物工程公司性质:1000-4999人公司地点:公司规模:--涉及领域:--公司网址: