Clinical Pathology, Manager/Senior Manager
Location: Shanghai

We are seeking a highly motivated clinical pathology/histology scientist to drive clinical pathology implementation to support clinical development programs across therapeutic areas in China.

Key responsibilities:
- Collaborate with clinical teams and diagnostic partners to support drug and diagnostic development in China.
- Work with global clinical imaging and pathology team, vendor management team, clinical operation team, etc. to ensure vendor validation and efficient execution of key assay setup, in the field of anatomic pathology and histology.
- Participate as a key contributor of molecular pathology and clinical pathology assay/lab documents (statement of work, lab manual, specimen collection procedure, etc.).
- Coordinate pathology 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.
- Provide expertise for pathology/histology related question in support of drug registration and applicable CDx registration

Qualifications
Required:
- MD or MD/PhD with formal training in Pathology/Histopathology with at least 5 years of experience in clinical diagnosis with top clinical institutions, pharmaceutical or global CRO labs
- Extensive technical experience in biomarker assays including but not limit to: in situ hybridization, immunohistochemistry, multiplex immunofluorescence, digital pathology
- Rich project experience working with investigators or pharmaceutical involving patient selection, biomarker strategies, and other relevant clinical trial activities.
- 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.
- Experience with clinical biomarker operations, including HGRAC application and project management, is highly valued.