Translational Medicine SD/ED(J31017)

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. 01

   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. 02

   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. 03

   Responsible for developing CDx strategies to align with clinical development program budgets and ensure successful implementation of companion diagnostic assays in clinical trials.

4. 04

   Work closely with internal and external teams to ensure timely completion of project plans and delivery of results.

5. 05

   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 and Qualification：DEGREE & MAJOR PhD degree；biology, translational medicine and other life science related. 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 More than 10 years of relevant experience in translational medicine. Have extensive experience in the field of oncology area. Familiarity with target/disease biology, preclinical and clinical development. Skill Requirement:Excellent organizational communication and coordination skills. Excellent spoken and written English skills Other Requirements :Good interpersonal and ownership.