Clinical Biomarker Operations Associate (contract 12-18 mos.)

Location: Cambridge, MA

Job Code:

Cambridge, MA-based H3 Biomedicine (H3B) is a leading company in cancer genomics driven drug discovery, delivering on the promise of precision medicine. The company was launched in 2011 with an unprecedented $200 million in initial funding from Eisai, plus a continued ongoing commitment to fund H3B’s robust discovery pipeline and clinical programs. Now with three clinical stage anti-cancer molecules in active development, H3B is able to uniquely leverage distinct insights from cancer genomics and real-life patient data to advance its projects to clinical proof of concept and beyond. H3B embraces a novel business model in which it collaborates with Eisai, a leading global pharmaceutical company, to create a prolific drug discovery engine and partnership platform.

This role is primarily focused on leading clinical biomarker activities and coordination between H3B clinical operations and data sciences groups as well as external vendors to ensure timely delivery of biomarker results for H3B clinical programs.

Principal Duties and Responsibilities

  • Biomarker sample logistics
    • Track the collection and shipment of biomarker clinical samples from the clinical site to biobanks or processing lab; working closely with CRO/ operations group to ensure all samples are collected and shipped according to schedule.
    • Coordinate shipments of samples to 3rd party laboratories for testing; tracking and confirming samples are received at vendors
    • Work closely with clinical operations/CROs and/or clinical sites to resolve sample related issues in a timely manner
  • Biomarker vendor and data management
    • Clear understanding of H3B programs clinical biomarker plan, to ensure documentation is aligned with the project team’s goals (laboratory manuals, informed consents, analytical plans, and SOWs).
    • Developing and updating data transfer specifications by gathering input from biomarker leads, data management and data scientists to get consistent data transferred to our internal systems
    • QC and monitoring of testing to ensure data provided by vendors meets H3B’s requirements.
    • Updating and maintaining internal Biomarker LIMS and database with data received from vendors or generated internally
  • Primary manager of the H3 Biomedicine biomarker group biobank
    • Responsible for receiving and registering into the biomarker LIMS system, clinical samples which will be processed in-house.
    • Coordinating shipments of clinical samples to off-site biobank for long-term storage upon completion of testing.
    • Sourcing commercial samples (both retrospective and prospective collections) from external biobanks/vendors to support H3B projects

Qualifications

  • BS/MS in Biological sciences with minimum 2 years experience, 5 years preferred, leading biomarker operations for clinical studies.
  • Prior experience with prospective biomarker testing and experience in pivotal clinical studies involving a diagnostic development is highly desirable.
  • Outstanding organizational skills and capacity to prioritize multiple tasks
  • Excellent people skills with ability to efficiently interface with multiple groups including clinical operations, data sciences and external CROs.

About H3 Biomedicine Inc.

H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.

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