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Clinical Biomarkers, Clinical Development, Contractor
1 month ago
FOCUS AREAS FOR THIS ROLE: Assays in immuno-oncology area, such as NGS, scRNAseq TCR sequencing, immunogencity, not all this is required but some are needed to be considered.
I have a hybrid opening with a pharmaceutical and the person can either work at the Cambridge, MA or Norwood, MA location dependent on there location. They would like someone onsite with the team at least 2 days a week and they cam be at home 3 days at either site. This is on their Clinical Biomarkers Team, Oncology, Clinical Development. They are looking for someone that has some who is flexible and adaptable and can work in a fast-paced environment. They are looking for someone with some of the technical expertise in these areas: **Variety of biomarker assays focusing in immuno-oncology area, such as NGS, scRNAseq TCR sequencing, immunogencity, not all this is required but some are needed to be considered.**
Duration: 6 months to start, possible to convert someone to a FTE if performed well and are a fit, this is not guarateed.
Title: Hybrid Contractor, Clinical Biomarkers – Oncology
Location: Cambridge, MA or Norwood, MA locations
Seeking a Contractor, Clinical Biomarkers to develop and drive biomarker plans across clinical stage Oncology programs. This position will work collaboratively across biomarker, translational, etc, teams (internal, external CROs) to ensure planning, execution and data delivery of biomarker lab data for clinical trials.
Here’s What You’ll Do: Bring in depth knowledge and technical expertise in variety of biomarker assays focusing in immuno-oncology area, such as NGS, scRNAseq TCR sequencing, immunogencity and others. Oversee assay development/implementation efforts in clinical biomarker team by partnering with preclinical and clinical biomarker lab teams to understand current assay status and potential vendor or internal laboratory requirements for oncology programs.
Responsible for overseeing vendors for timely and accurate completion of tasks and troubleshoot issues as it develops. Develop and provide operational input and recommendations into all study related documentation (including protocol, lab manual, informed consent form, and amendments) and processes, and ensure collection, delivery and analysis of bio-samples in compliance with these documents as well as GCP/ICH as neededContribute to evaluation of biomarker vendors by providing technical expertise in biomarker assays
Here’s What You’ll Bring to the Table:
MS or PhD (with at least 1-2 year of pharmaceutical or biotechnology experience) in a related science focus (i.e. immunology, Oncology).Hands on experience in biomarker assays such as NGS, RNAseq, TCRb sequencing, scRNAseq, cell based immunogenicity assays are required.Experience in clinical biomarker CRO management is required.
Knowledge in relevant biomarker assay qualification/validation, familiarity with assay development under regulated environment (CLIA, GCP/GCLP or equivalent) is preferred. Solid experience in the application of biomarkers during clinical development including experience with clinical translational research, development, validation and implementation of biomarkers in the Oncology space.Strong communication, organization and record keeping skills are required.
