Principal Scientist, Research Science - Genomics

Company: Hispanic Alliance for Career Enhancement
Location: Rahway
Posted on: April 27, 2025

Job Description:

Job DescriptionTranslational 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.The Genomics group within TMB is seeking a highly motivated and skilled candidate for the Principal Scientist position. This role is essential for developing, optimizing and deploying biomarker assays to enable clinical development at our company.Key responsibilities will include:

• Serve as a subject matter expert in the development and validation of genomics assays collaborating with clinical and biomarker leaders, as well as operations teams, biostatistics, companion diagnostics (CDx), and regulatory affairs.
• Interface with scientists in Discovery and Clinical development to strategically plan, execute and interpret genomics results from biomarker analyses, ensuring accurate conclusions are drawn.
• Execute and coordinate the development and fit-for-purpose validation of assays within TMB Genomics lab.
• Execute and coordinate the analysis of clinical samples.
• Identify and assess emerging genomics technologies and validate those that have use within a clinical trial setting.
• Collaborate and liaise with external partners and Contract Research Organizations (CROs) to manage the development, validation and execution of genomics assays to support all therapeutic areas.
• Write memos, final reports and publications summarizing data and present findings to clinical and other internal stakeholders.Position Qualifications:Education Minimum Requirement:
  • Ph.D., MD or MD/PhD in a life sciences discipline (Biochemistry, Immunology, Genetics, Molecular Pathology, Cell Biology, etc.) or ChemistryRequired Experience and Skills:
    • A minimum of 10 years of pharmaceutical or related experience.
    • A minimum of 5 years of industry experience in Genomics.
    • 3+ years of research experience is required with an MD.
    • Experience leading liquid biopsy (e.g. cfDNA, ctDNA, cfDNA methylation, etc.), biomarker research, assay development and validation.
    • A combination of experience with various NGS platforms, qPCR, digital PCR, and other genetic/genomic assay platforms.
    • Understanding of standards and guidelines for analytical method validation.
    • Strong record of scientific achievement (publications, patents, internal/external scientific/technical presentations, etc.).
    • Strong interpersonal, verbal and written communication skills.
    • Able to work independently, represent TMB Genomics on multiple projects.
    • Strong leadership skills.
    • Ability to execute within a matrixed organization.Preferred Experience and Skills:
      • Precision medicine expertise in Oncology and/or Immunology fields.
      • Broad knowledge of drug development process and translational medicine.
      • Experience with the design and development of Minimal Residual Disease (MRD) assays, TCR/BCR repertoire sequencing and analysis is advantageous.
      • Molecular Genetic Pathology or Laboratory Medicine training.Employee Status: RegularRelocation: Domestic/InternationalVISA Sponsorship: YesTravel Requirements: 10%Flexible Work Arrangements: HybridJob Posting End Date: 04/30/2025
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Keywords: Hispanic Alliance for Career Enhancement, Passaic , Principal Scientist, Research Science - Genomics, Other , Rahway, New Jersey