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Contractor, Clinical Biomarkers
3 months ago
Contractor, Clinical Biomarkers - Oncology
Cambridge OR Norwood MA (2-3 days/week)
6 Month Contract | Intent to convert to FTE based on performance
Seeking a Clinical Biomarker - Oncology, Contractor
MUST HAVE (below technical experience in Pharma OR Biotech)
- MS or PhD in a related science focus (immunology, Oncology)
- Biomarker assay experience: NGS, RNAseq, TCRb sequencing, scRNAseq, cell based immunogenicity assays
- Experience in Clinical Biomarker CRO Management
- Biomarker assay qualification/validation, assay development under CLIA, GCP or GCLP
- Biomarker experience within clinical development (clinical translational research, development, validation and implementation of biomarkers in the Oncology space)
The ideal candidate is adaptable/flexible (this is a fast paced environment, structure & processes not always well defined) Looking for someone that's engaged, communicates proactively, is eager to learn, and willing to speak up to identify a challenge and/or make suggestions.
Seeking a Clinical Biomarker - Oncology, Contractor 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 conducted by company.
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 needed
- Contribute to evaluation of biomarker vendors by providing technical expertise in biomarker assays
POSITION REQUIREMENTS
- MS (with at least 6 years pharmaceutical/biotechnology experience) or PhD (with at least 1 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.
