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Associate Director, Clinical Biomarkers, Oncology
2 months ago
The Role:
Moderna is seeking a Clinical Biomarker leader to drive biomarker assay plans across clinical stage oncology programs. This position reports to Moderna's Director of Clinical Biomarkers. The Associate Director will work collaboratively across several clinical teams (internal, external CROs) to ensure biomarker assay development strategy, planning, execution, and data delivery of biomarker lab data for clinical trials conducted by Moderna.
Key Responsibilities:
- Evaluate technologies to identify, define, and implement fit-for-purpose biomarker assays to support the clinical development of Moderna's oncology pipeline.
- Work in collaboration with clinical biomarker lab, translational, and research teams to support overall biomarker assay development strategies for oncology programs and bring a deep understanding of relevant biomarker technologies to teams.
- Bring deep technical knowledge and hands-on experience of molecular biomarker technologies such as NGS, Immunoassays, Immunophenotyping, Image-based assays, and emerging technologies such as cell-free DNA assessments.
- Have a broad understanding of new technological advances in Oncology and potential utilization of these to address current and future needs within the Oncology portfolio.
- Lead 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 to ensure assay labs complete appropriate development, qualification, or validation studies in order to execute the clinical biomarker plan on time and with good quality for Oncology clinical biomarker assays.
- Manage biomarker assay labs to complete appropriate development, qualification, or validation studies in order to execute the clinical biomarker plan on time and with good quality.
- PhD (with at least 5 years pharmaceutical/biotechnology experience) or MS (with at least 8 years of pharmaceutical/biotechnology experience in an oncology science, expertise in clinical biomarker assay development highly desirable).
- Hands-on experience in Immuno-Oncology assays, such as NGS, Flow-based assays, multiplex immunofluorescence, immunohistochemistry, etc., required.
- Experience in CRO management, biomarker assay qualification/validation, familiarity with assay development under regulated environments (CLIA, GCP/GCLP or equivalent) 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, interpersonal, and record-keeping skills required.
Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop innovative medicines. We are committed to advancing the field of mRNA-based therapeutics and vaccines, and we are seeking talented individuals to join our team. As a Clinical Biomarker leader, you will play a critical role in driving the development of biomarker assays for our oncology pipeline. If you are passionate about biomarker development and have a strong background in oncology, we encourage you to apply for this exciting opportunity.
