Job Description:

As China Precision Medicine-Pathologist/Pathology Lab Leader, you will provide expertise in human disease pathology, experimental pathology support and contribute to the development and interpretation of tissue-based assays across therapeutic areas. You will also be responsible for pathology lab/team setup, project management, data analysis and interpretation of pathology lab testing results.

Key Responsibilities

Specific responsibilities can include:

• Lead China pathology lab/project development teams or sub-teams. Coordinate with appropriate team members to advance projects efficiently. Focus of the position will be to provide pathology support needed for spatial biology and single cell genomics.
• Contribute to or Lead the design and interpretation of tissue-based studies investigating aspects such as target biology, drug MOA, target pathway activation, pharmacodynamic effects, biomarker prevalence, or drug distribution.
• Contribute to the design, validation and deployment of pathology assays, including the determination of assay parameters such as specificity and sensitivity. Design, implement and oversee pathology-based biomarker and diagnostic testing, including data analysis:
• Develop, validate and implement scoring paradigms for tissue-based assays
• Direct the development, outsourcing and validation of clinically applicable tissue-based assays. Assist in the development of assay protocols as needed.
• Provide pathology input to project teams and ensure access to state-of-the-art tissue-based techniques and samples for target pathway evaluation in human disease:
• Implement technologies and/or methodologies via a combination of in-house efforts and the use of CROs or other external expertise using techniques such as in situ hybridization, immunohistochemistry (including multiplexed), spatial biology image analysis, etc.
• Evaluate the scientific basis and clinical applicability of the proposed assays, their validation status and any related technical issues.
• Assume responsibility for the assessment and scoring of specimens and the preparation of reports summarizing the data, analysis and interpretation of findings.
• Write the relevant pathology-based biomarker and diagnostics testing sections in drug development and registration documents such as clinical study protocols, clinical study reports, investigator brochures, and regulatory submission packages (INDs, NDA’s, BLA's).
• Collaborate with project teams from concept to reagent generation to quantitation and approval plan for CDx as needed.
• Participate in the evaluation of external licensing or collaborative opportunities (including CDx collaborations) and oversee internal components of shared programs.