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Senior Clinical Manager
3 months ago
Sr. Manager, Clinical Biomarkers - Oncology
- Pay Rate: 90-100 per hour
- 4-month contract covering a leave, maybe some opportunity to extend
- This position is hybrid, in Cambridge 2-3 days a week.
Seeking candidates with the following:
- This person should have technical knowledge of different assay types, of different validation types, and will be managing CROs from an assay validation perspective and moderating Data QC from vendors.
- This person must have pharmaceutical/sponsor experience.
- This person should have one of the three: GLP/GCLP/CLIA
The Role:
Moderna is seeking a Sr. Manager, Clinical Biomarkers to develop and drive biomarker plans across clinical stage Oncology programs. This position reports to Moderna’s Associate Director of Oncology, Clinical Biomarkers. The Senior Manager will work collaboratively across biomarker and translational teams (internal, external CROs) to ensure planning, execution, and data delivery of biomarker lab data for clinical trials conducted by Moderna.
Here’s What You’ll Do:
- Bring in-depth knowledge and technical expertise in a variety of biomarker assays focusing on immuno-oncology, such as immunogenicity, immunophenotyping, TCR sequencing, immunohistochemistry, and other biomarker assays.
- Oversee assay development/implementation efforts in the 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.
- Be responsible for overseeing vendors for timely and accurate completion of tasks and troubleshooting issues as they develop.
- 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 the evaluation of biomarker vendors by providing technical expertise in biomarker assays.
Here’s What You’ll Bring to the Table:
- PhD (with at least 1 year of pharmaceutical or biotechnology experience) or MS (with at least 6 years of pharmaceutical/biotechnology experience) in a related science focus (e.g., immunology, oncology).
- Hands-on experience with biomarker assays such as cell-based immunogenicity assays, multiparametric flow cytometry, multiplex cytokine assays, immunohistochemistry, etc. is required.
- Experience in clinical biomarker CRO management is required. Knowledge of relevant biomarker assay qualification/validation requirements and familiarity with assay development under regulated environments (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.
