The Senior Manager will oversee outsourced pharmacokinetic and immunogenicity assays for nonclinical and clinical studies. The individual will select bioanalytical CROs, develop contracts, protocols and analysis plans and coordinate timelines and activities in collaboration with project management. The individual will oversee assay transfer, validation and implementation at CROs. In addition, the individual will critically review data and reports, prepare relevant sections of regulatory submission documents, and participate in regulatory meetings. The individual will also be responsible for assessing GLP compliance and scientific capabilities of CROs.
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