Manager, Clinical Biomarker Assays – Translational Science, Neuroscience
Arvinas
full-time
Posted on:
Location Type: Hybrid
Location: New Haven • Connecticut • United States
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About the role
- Conduct scientific and operational due diligence and selection of external biomarker CROs and assay platforms, leading vendor due diligence processes including, but not limited to assessment of biomarker technology, evaluations of biomarker assay feasibility, analytical performance and validation characteristics, and overall technical capability.
- Lead and oversee development, qualification, and validation of clinical biomarker assays (e.g., ELISA, Simoa, MSD, LC-MS/MS, Olink/SomaScan, NGS etc) in collaboration with internal teams and CROs, including review of assay analytical validation plans, biomarker reports, and technical documentation to ensure timely clinical biomarker assay deliverables and biomarker assay performance meets regulatory and industry standards for clinical use (e.g., GCLP, CLIA, CAP as applicable).
- Oversee external CROs/labs performing clinical biomarker testing, including vendor management. assay transfer and clinical sample testing. Ensure high-quality biomarker data generation, QC, and timely data transfer
- Cross-functional collaboration with Translational Sciences Lead, Clinical Operations, Biosample Operations, Data Management, and external vendors to ensure execution of biomarker readouts in our clinical studies.
Requirements
- 5+ years (industry preferred) in clinical biomarker assay development and/or bioanalytical sciences.
- Demonstrated experience managing external CROs and central laboratories
- Demonstrated experience with protein biomarkers (such as fluid (including CSF) and tissue biomarkers, blood-based biomarkers), and genomic platforms (e.g., Simoa, MSD, Olink, mass spectrometry, NGS)
- Experience with neuroimaging biomarkers (e.g., PET, MRI) and/or digital biomarkers preferred.
- Familiarity with clinical data standards and biomarker data transfer processes.
- Experience working in neuroscience and/or rare diseases such as Parkinson’s disease, PSP, Alzheimer’s disease, or related disorders preferred
- Experience supporting IND-enabling or early-phase clinical trials preferred
- Demonstrated success in working cross-functionally within multidisciplinary teams.
- Excellent communication, organizational, and problem-solving skills, with the ability to operate independently in a matrixed environment.
- Arvinas will not be providing VISA sponsorship for this position. You must have the ability to work without a need for current or future VISA sponsorship.
Benefits
- group medical, vision and dental coverage
- group and supplemental life insurance
- competitive package of base and incentive compensation
- comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
biomarker assay developmentbioanalytical sciencesELISASimoaMSDLC-MS/MSOlinkSomaScanNGSmass spectrometry
Soft Skills
communicationorganizationalproblem-solvingcross-functional collaborationvendor managementindependent operationmatrixed environment