Bioanalyst
Core
Develop and implement bioanalytical assays for clinical-stage oncology candidate drugs, overseeing CROs and ensuring regulatory compliance.
Role type
Senior IC bioanalyst (clinical bioanalysis)
Builds
Bioanalytical assays and data for clinical trials
Domain
Oncology / Clinical Bioanalysis
Required skills
Bioanalytical assay development, CRO management, Regulatory compliance (GLP/GCLP/ICH M10), Method validation, LC-MS/MS, Ligand-binding assays, Clinical study protocol authoring, Regulatory submissions (IBs/CTDs/INDs/BLAs)
Preferred skills
Experience with ADCs, Small molecules, Large molecules
Technologies
LC-MS/MS, Ligand-binding assays
Responsibilities
Develop and implement bioanalytical assays for compounds in clinical development; Oversee CROs performing bioanalytical lab work; Author sections of clinical study protocols, analysis plans, reports, and regulatory submissions; Partner with cross-functional teams to ensure program progression.
Seniority
Senior, hands-on IC