Head of Regulatory Bioanalysis

Role: Head of Regulatory Bioanalysis leading a team within Clinical Pharmacology and Safety Sciences to support discovery, preclinical, and clinical phases across therapeutic areas. Responsibilities: develop strategic scientific direction, oversee bioanalytical testing for PK, biomarkers, and immunogenicity, ensure regulatory compliance, manage test facilities, and facilitate interface with health authorities globally. Requirements: PhD or MSc with ≥10 years’ leadership experience in regulatory bioanalysis, proven talent development, and expertise in bioanalytical methods such as mass spectrometry and ligand binding assays. HighValue: leadership in bioanalysis, regulatory submission expertise, global health authority interactions, and experience across modalities, including biologics and small molecules, in late-stage development or post-market. WorkSetup: hybrid in Gaithersburg, MD; travel details not specified.