Sr. Scientist -Biomarkers, assay development, Flow Cytometry
- Sct as a point of contact between the Biomarker Analysis group, clinical teams and CROs. Will oversee the outsourcing of clinical biomarker assay development, validation and sample analysis.
- Collaborate with functional groups to develop and implement clinical biomarker strategies supporting all therapeutic areas and stages of drug development.
- Develop and implement fit-for-purpose clinical biomarker assays at external CROs to support biomarker driven global clinical trials.
- Evaluates vendor validation and clinical analysis plans.
- Provide input on biomarker related sections of clinical study protocols including the necessary sample collection, processing and shipping requirements.
- Evaluate, interpret and present complex scientific data.
- Identify appropriate vendors and participate in vendor evaluation/selection for biomarker assay development, validation and sample analysis across diverse technology platforms.
- PhD in biological sciences or related field
- 5+ years of related industry experience in fit-for-purpose clinical assay development, validation and implementation in support of multisite clinical trials.
- Must have experience overseeing the establishment of biomarker assays at CROs.
- Experience working in a GLP or GLP-like environment highly preferred.
- A strong preference for a candidate with broad technical experience (e.g. Immunochemistry, flow cytometry, genomics and molecular pathology).
- Ability to work independently as well as collaboratively in a matrixed team environment.
- Strong oral and written and interpersonal skills required
Keywords: Clinical Biomarker Outsourcing, Fit-For-Purpose, Data Interpretation, Assay Development, Assay Validation, Clinical Study Reports, Flow Cytometry, Genomics, Molecular Pathology, GLP, Pre-Analytics,CRO evaluation
***For immediate consideration, please email your updated resume to Apex Life Sciences at [Click Here to Email Your Resumé] with 'Scientist Biomarkers' in the subject line.
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