Executive Director, Head of Bioanalytical Sciences

Role: Executive Director, Head of Bioanalytical Sciences, leading strategy and execution of bioanalytical and biomarker assays across research, translational, and clinical development for autoimmune disease therapies. Responsibilities: define and implement bioanalytical strategy, oversee assay development and validation (PK, PD, immunogenicity, biomarkers), ensure regulatory compliance, build and lead a high-performing team, manage CROs and external labs, and support regulatory submissions and interactions. Requirements: PhD or equivalent in biochemistry, immunology, pharmacology, analytical chemistry, or related field; 15+ years in biotech/pharma/CRO with leadership in bioanalytical functions; deep expertise in assay development, validation, and lifecycle management; comprehensive knowledge of platforms including LC-MS/MS, ligand-binding, cell-based, flow cytometry, and molecular methods; strong understanding of GLP/GCP regulations and regulatory expectations. HighValue: biologics, autoimmune indications, biomarker development, clinical-stage (Ph1-3), regulatory support, GxP compliance, cross-functional leadership, external vendor management, remote work environment.