Associate Principal Scientist, Clinical Flow Cytometry

Job Description

Translational Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of clinical development at our Company's Research laboratories. TMB laboratories leverage a diverse array of technologies to develop biomarker assays to help confirm engagement of therapeutic targets and understand mechanisms of drug action and patient response.

Position Overview:

The Flow Cytometry group within TMB is seeking a highly motivated and skilled individual for the Associate Principal Scientist position. This role is vital for the development, validation, oversight, and troubleshooting of flow cytometric assays that are pivotal in supporting our clinical trials. The ideal candidate will possess robust technical and scientific expertise in flow cytometry, immunology, oncology, cell biology, and molecular biology, and show a strong interest in lab-based assay work. Additionally, the candidate should have experience collaborating closely with external partners to provide scientific and technical oversight for flow cytometric assays supporting our pipeline.

Key Responsibilities:

• Lead the transition of biomarker flow cytometry assays from Preclinical Research to Clinical Development.

  • Design, develop, and optimize flow cytometric assays across all therapeutic areas and clinical development phases.

  • Provide technical guidance on fit-for-purpose assay validation and troubleshoot assay and instrument-related issues.

• Collaborate and liaise with external partners and Contract Research Organizations (CROs) to manage the development, validation, and execution of flow cytometry assays.

  • Draft and review Statements of Work (SOWs), Workplans, Development Testing Agreements (DTAs), and Data Transfer Specifications (DTSs).

• Serve as a subject matter expert in flow cytometry, working with project teams, biomarker leaders, clinical operations, regulatory affairs, and physicians to implement assays and execute biomarker strategies for clinical trials.

• Prepare memos, final reports, and publications summarizing data and update lab Standard Operating Procedures (SOPs).

Position Qualifications:

Education Minimum Requirement:

• BS, BA, MS, or Ph.D. in a life sciences discipline (e.g., Biochemistry, Immunology, Cell Biology).

Required Experience and Skills:

• Experience: 13 years (BA/BS), 8 years (MS) and 3 years (PhD)

• Technical Expertise: Strong understanding of translational medicine and biomarker development with extensive knowledge and experience in flow cytometry techniques, including panel design, assay development, optimization, and validation.

• Instrument Expertise: Experience with flow cytometers (e.g., BD, Cytek) including maintenance, troubleshooting, and performance optimization.

• Data Analysis Skills: Proficient in data analysis and interpretation, using software tools such as FlowJo, OMIQ, and FCS Express, with the capability to derive actionable insights from complex datasets.

• Regulatory Knowledge: Understanding of regulatory guidelines (FDA, EMA) pertaining to biomarker development and clinical trial processes.

• Project Management: Proficient project management skills to effectively plan, coordinate, and prioritize activities to achieve project goals.

• Communication Skills: Excellent interpersonal, verbal, and written communication capabilities.

• Leadership Abilities: Highly motivated, capable of working independently, and possessing strong leadership skills.

• Collaborative Mindset: Ability to execute within a matrixed organization and collaborate across functions.

Preferred Experience and Skills:

• In-depth knowledge of the latest advancements and trends in flow cytometry and translational medicine.

• Expertise in the design and development of various flow cytometry assays, including but not limited to:

  • Immunophenotyping

  • Minimal Residual Disease (MRD)

  • Receptor Occupancy

  • High-dimensional Flow Cytometry

  • Tumor-Infiltrating Lymphocytes (TILs)

  • Phospho-signaling

  • Intracellular Cytokine Profiling

  • Cellular Proliferation

• Experience working with CROs, demonstrating skills in clear communication, protocol transfer, quality agreements, secure data transfer, and regulatory compliance.

• Proficiency in handling primary cells d