Study Manager, Clinical Flow Cytometry
TITLE AND CLASSIFICATION: Study Manager, Clinical Flow Cytometry (TOS)
REPORTING LOCATION: Rockville, MD
REPORTING TO: Head Flow Cytometry
PRIMARY OBJECTIVES: Oversee clinical flow cytometry operations for Champions Oncology. Provide technical expertise in flow cytometry, and scientific leadership in immunology, oncology and general drug development. Responsible for maintaining high quality flow cytometry data generation and interpretation. Start and maintain a GxP compliant flow cytometry laboratory to support clinical trial sample analysis. Manage and develop staff. Perform project management for clinical flow cytometry work, interacting directly with Sponsors to ensure protocol adherence, provide status updates, and communicate progress. Generate novel methods and/or work with method developers to develop, transfer, and validate appropriate flow cytometry assays. Schedule staff to allow for clinical flow work to occur as needed to ensure sample processing within stability timeline requirements. Ensure quality sample analysis, data QC and reporting within defined timelines. Some client-facing interactions will be required. Working with Business Development to assist in inquiries and marketing promotions. Frequent direct interactions with clients prior, during, and after study completion, performing project and program management assistance as it relates to flow cytometry data.
DUTIES AND RESPONSIBILITIES
- Technical and general scientific expertise
- Flow Cytometry technical guidance
- Responsible for quality and accuracy of panel design, data acquisition and analysis
- Generate novel methods and/or work with method developers to develop, transfer, and validate appropriate flow cytometry assays
- Responsible for the quality and efficiency of studies performed within the clinical flow cytometry laboratory.
- Responsible for reporting of clinical flow cytometry sample data
- Business and management:
- Project management: lead analysis of clinical flow cytometry data and reporting of results.
- Responsible for managing and mentoring staff
- Responsible for scheduling and planning to effectively manage workload
- Regulatory knowledge of GxP within analytical and/or flow cytometry analytical operations.
- Serve as Lab Co-Director for CLIA approved flow cytometry.
- Maintains CLIA compliance and approval.
- Responsible for HIPAA compliance
- Sales and marketing
- Works directly with Business Development and Clinical Operations teams.
- Assist business development by providing input into and review of enquiries and statements of work for large clinical and preclinical contracts.
- Ability to interact directly with customers.
KNOWLEDGE, SKILLS, AND ABILITIES
- Flow cytometry knowledge in panel design, method development, analysis, and interpretation of multicolor flow cytometry in multiple species including mouse and human.
- Experience with 8+ color flow cytometry.
- Experience with flow cytometry analysis software (BD FACSuite, Diva, FCS Express, FlowJo, etc.).
- Experience in immunology, oncology, and cell biology. Prior drug development experience helpful.
- People management experience leading a team of professional staff productively in a team-oriented environment while maintaining a strong sense of integrity and confidentiality.
- Prior experience with lab oversight, including work scheduling, equipment maintenance, reagent inventory, sample throughput.
- Prior experience with regulatory analytical laboratory environments, including Quality Assurance, adherence to GxP, SOP writing, method validations, audit responses, and training and compliance.
- Prior experience with CLIA, CAP proficiency testing and/or NY State Department of Health Clinical Laboratory Evaluation Program
- Project management of clinical flow cytometry studies. GANNT charts, periodic update meetings with clients, and general oversight of clinical studies.
- Creative problem-solving skills and the ability to exercise sound and accurate judgment in making timely decisions.
- Demonstrated accountability and responsibility for own work.
- Ability to observe safety and security procedures.
- Proficiency with teamwork, multitasking, organization, written and verbal communication skills.
- Ability to assist with other tasks/duties as needed in a small company environment.
EDUCATION AND EXPERIENCE
- D. with 2+ years’ experience, M.S. with 6+ years’ experience, or equivalent experience in multicolor flow cytometry
- Previous experience managing research staff
- Previous experience in a regulatory flow cytometry operation
- Prior CRO experience helpful
- Oncology, immunology, and drug development expertise preferred
- GLP, GCP, CAP or CLIA experience required
- Up to 10% travel
This job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary.