Director, Clinical Flow Cytometry
About the Job
The Clinical Flow Cytometry group is responsible for supporting a book of work comprised of several dozen individual projects in the Oncology, Immuno-Oncology and Immunoscience portfolios. The group primarily focuses on validating and implementing flow cytometry assays in the early clinical translational research space. Members of this team work on various projects in concert with multiple groups including oncology devlelopment teams, translational biology, biomarkers and pharmacodiagnostics. The group is responsible for the application of flow cytometry-based technologies for measurement of important endpoints in clinical studies which support 1) mechanism of action hypotheses, 2) pharmacokinetic-pharmacodynamic evaluations, and 3) identification of novel biomarkers related to clinical response. Additional key responsibilities include overseeing the execution of flow-cytometry work at external partners, and collaborating to provide technical expertise and analytical guidance for critical academic partnerships with BMS.
Delivers high quality flow cytometry based biomarker assays for target engagement, pharmacodynamic endpoints and patient selection.
Ensures that analytically validated fit for purpose assays are developed and delivered to support early clinical development
Manages internal and external laboratories for whole blood/PBMC sample processing and flow-cytometry based analysis
Make critical strategic decisions to forecast and manage the demand of flow-cytometry assays, including viable outsourcing strategies that maximize delivering clinical data on time with high quality, while minimizing risks to development programs.
Manages a complex series of relationships with external vendors, in conjunction with a matrixed team at BMS, to ensure that vendors provide assay validation and sample results according to transferred methods and procedures.
Oversees the quality of transferred assays and ensures that results from both internal and externally sourced assays are provided in real-time to support decision making in clinical trials.
Ensures appropriate CLIA certification for flow-based patient selection assays as necessary
understand, implement and ensure good clinical laboratory practices
Be responsible for the career development and performance management of a group of 10 -20 researchers with varying levels of experience and responsibilities in the flow laboratory.
Provides both strategic and tactical direction, and resource prioritization, as well as acting as a resource for troubleshooting as necessary.
Provides biomarker expertise to the Center of Excellence in Pharmacodiagnostics and partners to progress appropriate validated biomarkers into diagnostic development. Leadership & Matrix Alignment
- Acts as an active contributor to the Biomarker Technology matrix team, continuously seeking opportunities to optimize interfaces and processes to delivery highest quality biomarker data to clinical programs
A Ph.D. in Biomedical Sciences. Immunology or Oncology a plus.
minimum of 8 years experience beyond post-doc.
At least 5 years of experience in an industrial setting. Within diagnostics or translational biomarker setting a plus.
Demonstrated excellence in managing flow cytometry research projects
Familiarity with the techniques common to translational research including flow cytometry, genomics, proteomics and importantly, data analysis.
Excellent communication skills.
Experienced manager of people and projects.
Ability to interact well with senior managers and develop and articulate a strategy for translational research.
Understanding of good clinical laboratory practices
Familiarity with CAP/CLIA regulations a plus