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.
high quality flow cytometry based biomarker assays for target engagement,
pharmacodynamic endpoints and patient selection.
that analytically validated fit for purpose assays are developed and
delivered to support early clinical development
internal and external laboratories for whole blood/PBMC sample processing
and flow-cytometry based analysis
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.
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
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.
appropriate CLIA certification for flow-based patient selection assays as
implement and ensure good clinical laboratory practices
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.
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
- 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
- Familiarity with the techniques common to translational
research including flow cytometry, genomics, proteomics and importantly,
- 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