Head of Oncology and Cell Therapy Flow Cytometry

Precision Life Sciences - Boston, MA

Our client is seeking a strong scientific and strategic leader to head the clinical flow cytometry efforts. The Head of Oncology and Cell Therapy Flow Cytometry is an exciting, new role within the growing Precision & Translational Medicine (PTM) function in the Oncology Therapeutic Area Unit (OTAU) reporting to the Head of Clinical Biomarker Sciences and Operations.

The individual recruited for this new role will serve as the PTM resident flow cytometry assay expert, whose role includes advising translational scientists on the best practices for implementing flow cytometry-based biomarker assays/technologies into oncology Phase 1-3 clinical trials. The candidate will build an innovative, industry-leading oncology and cell therapy flow cytometry function responsible for establishing and piloting innovative flow cytometry technologies. They will identify and establish relationships with high-quality external flow cytometry partners, transfer flow cytometry assays to external partners for validation, and oversee assay implementation in clinical trials and QC data to support primary, secondary and exploratory endpoints supporting Phase 1-3 clinical trials.

 

Accountabilities
The Head of Oncology and Cell Therapy Flow Cytometry will

  • Build from the ground up and lead a high-performing, innovative, flow cytometry team responsible for overseeing assay development, qualification, validation, technology transfer, and data interpretation from standard and highly multiplexed flow cytometry assays.
  • Oversee assays run under-regulated approaches (GLP, GCP, GCLP, CAP/CLIA) and QC data to support primary, secondary and exploratory clinical trial endpoints.
  • Understand the entire flow cytometry workflow from sample collection, processing, and analysis through data generation.
  • Evaluate, select, and oversee external labs to ensure successful design and execution of clinical assays, including feasibility, validation, longitudinal performance, and data quality.
  • Review and approve flow cytometry-related components and interpretation of data in regulatory submissions (INDs, NDAs, BLAs, PMAs, etc.).
  • Attend and participate in key program team meetings (e.g., clinical and translational subteams) to provide insight and support for multi-color flow cytometry using both conventional and spectral flow cytometry, CyToF, and other cytometry-based platforms.
  • Collaborate with translational scientists to design experiments that leverage flow cytometry data to support clinical drug development.
  • Review DTS and DTA agreements and have a good understanding of CDISC terminology
  • Collaborate with individuals from other functions including Computational Oncology to further analyze and interpret data in context with other clinical data.
  • Recruit, mentor, develop and retain talent.

Education And Experience

  • A Ph.D. and above in Immunology, cell biology, or related discipline with at least 8 years of relevant experience beyond post-doctoral training, including at least 2 years of industry experience supporting oncology clinical development.
  • Experience in establishing a flow cytometry laboratory.
  • Prior management experience preferred including recruiting, coaching, and developing the key talent required.
  • Strong scientific background and experience with assay development and validation across multiple flow cytometry technology platforms, especially those that are employed in clinical trials.
  • Demonstrated ability to design and validate highly complex high parameter flow panel (up to 34 plex)
  • Experience working with instruments such as BD Canto, Lyric, LSR, Fortessa, and Cytek Aurora
  • Deep experience with the analysis of flow data with proficiency in one or more data analysis packages (e.g., FlowJo, OMIQ, FCS Express, FACS Diva, etc.).
  • Experience with outsourcing and working with external academic and CRO partners to develop/transfer assays, oversee data generation/analysis, and delivery of high-quality data from global clinical trials in under-regulated settings (GLP, GCP, GCLP, and CAP/CLIA, etc.).
  • Thorough understanding of receptor occupancy assay development and CAR enumeration assays
  • Deep knowledge of clinical flow cytometry assay validation guidelines
  • Familiarity with clinical documents and processes, such as clinical protocols, informed consent forms, laboratory manuals, sample management forms Data transfer agreements, etc.
  • Experience with advanced analysis tools such as deep learning algorithms or AI and/or other technologies such as molecular pathology and genomics is a plus.
  • Experience identifying, evaluating, and establishing flow cytometry partners to support global clinical trials in countries including Japan, China, Brazil, and European countries.
  • Strong written and oral communication skills

Travel Requirements

  • Ability to drive to or travel to conferences, partner meetings, and laboratory audits as needed, including overnight trips. Some international travel may be required
  • Requires approximately 5 - 15% travel

 



Posted On: Wednesday, July 20, 2022



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