Biomarker Operation, Senior Manager
Location: Shanghai

We are seeking a highly motivated scientist to drive clinical biomarker operation implementation to support clinical development programs across therapeutic areas in China.
Key responsibilities:
- She/He will be working with global and China biomarker lead and/or platform lead to develop China biomarker strategy and implementation plan to support clinical development programs across therapeutic areas.
- Work global vendor management team, biomarker operation project management team, companion diagnostic operation team to ensure vendor validation and efficient execution of key assay setup.
- Collaborate with cross-functional study team for relevant biomarker sections of clinical study documents (clinical trial protocol, ICF, etc.).
- Participate as a key contributor of biomarker assay/lab documents (statement of work, lab manual, specimen collection procedure, etc.).
- Coordinate biomarker sample and assay logistics planning/execution and serve as a key point of contact in China with vendors/study teams for issue resolution.
- Develop project plans with clearly defined timelines and deliverables and implement necessary risk mitigation strategies.
- Contributes to biomarker study design, assay platform selection and data analysis of investigator-initiated studies.
Qualifications
Required:
- M.S. or Ph.D. in the Life Sciences related subjects and with at least 5 years’ experience in pharmaceutical (translational medicine) or global CRO lab (pathology/genomic).
- Broad technical experience in biomarker assays including but not limit to: IHC, immunoassay, flowcytometry, genetics/genomics.
- Understanding of drug discovery & development including early/late-stage development, approval process and life cycle management.
- Must be detail oriented with strong organization skills in order to manage and meet deliverables.
- Demonstrate exceptional written and verbal communication skills in English and Chinese.
- Experience with a matrix environment and ability to effectively collaborate with colleagues from a wide range of disciplines.
Preferred:
- Understanding of drug development process, and key concepts in clinical trial study.
- Understanding of the major concepts of oncology biology.
- Record of publishing in high profile scientific journals.
- Experience with clinical biomarker operations, including HGRAC application and project management, is highly valued.