Oncology Clinical Biomarkers Specialist

1 week ago


Cambridge, Massachusetts, United States Randstad Life Sciences US Full time

Position Overview: We are seeking a skilled Contractor for Clinical Biomarker Development to enhance and manage biomarker strategies within clinical stage Oncology programs.

Key Responsibilities:

  • Utilize extensive knowledge and technical proficiency in various biomarker assays, particularly in the immuno-oncology sector, including NGS, scRNAseq, TCR sequencing, and immunogenicity.
  • Collaborate effectively with internal and external teams, including biomarker and translational teams, to ensure the successful planning, execution, and delivery of biomarker lab data for clinical trials.
  • Oversee the development and implementation of assays within the clinical biomarker team, partnering with preclinical and clinical laboratory teams to assess current assay statuses and identify vendor or internal laboratory needs for oncology initiatives.
  • Manage vendor relationships to ensure timely and accurate task completion while addressing any emerging issues.
  • Provide operational insights and recommendations for all study-related documentation, including protocols, lab manuals, informed consent forms, and amendments, ensuring compliance with GCP/ICH standards.
  • Contribute to the evaluation of biomarker vendors by offering technical expertise in biomarker assays.

Qualifications:

  • Master's or PhD degree in a relevant scientific discipline (e.g., immunology, oncology) with a minimum of 1-2 years of experience in the pharmaceutical or biotechnology sectors.
  • Hands-on experience with biomarker assays such as NGS, RNAseq, TCRb sequencing, scRNAseq, and cell-based immunogenicity assays is essential.
  • Experience in managing clinical biomarker CROs is required.
  • Familiarity with biomarker assay qualification/validation and experience in a regulated environment (CLIA, GCP/GCLP or equivalent) is preferred.
  • Demonstrated experience in applying biomarkers during clinical development, including clinical translational research, development, validation, and implementation in the oncology field.
  • Strong communication, organizational, and record-keeping skills are essential.


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