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Executive Director Bioanalytical Sciences

VirtualVocations
Durham, North Carolina, United States
Full-time

A company is looking for an Executive Director, Bioanalytical Sciences to lead bioanalytical assay development and validation functions.

Key ResponsibilitiesDesign and execute bioanalytical aspects of clinical studies in collaboration with the clinical research teamDevelop, validate, and maintain bioanalytical methods with CROs to support clinical studiesOversee regulatory compliance and author relevant documentation for regulatory submissionsRequired QualificationsPhD in Chemistry, Biochemistry, or related discipline with a minimum of 14 years of experience in biopharmaExtensive experience in managing bioanalytical studies for protein therapeuticsProven experience in developing and validating bioanalytical methods for PK, ADA, and biomarkersExpertise in ligand-binding assays, LC-MS, and bioanalytical techniquesExperience managing global CROs and establishing regulated assays

3 days ago
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