Associate Director, Bioanalytical Development

Role: Associate Director, Bioanalytical, leading strategy and execution for bioanalytical assays supporting biopharma programs involving small molecules and biologics. Responsibilities: define assay plans, manage CRO/vendor performance, oversee end-to-end bioanalytical workflows—including PK/TK, immunogenicity, and metabolites—to ensure data quality, regulatory compliance, and readiness for submissions; collaborate with cross-functional teams on study design, sample logistics, and data interpretation; support scaling of the Trial Engine platform through standardization efforts. Requirements: PhD with 7+ years or relevant undergraduate with 10+ years in bioanalytical support within clinical-stage biopharma; expertise in LC–MS/MS, biologics bioanalysis, immunogenicity assay development, and validation; experience managing external vendors and understanding regulatory expectations for GxP bioanalysis; strong communication skills. Preferred: experience integrating bioanalysis within clinical teams, GCP/GCLP familiarity, and sample logistics planning. HighValue: focus on clinical programs involving small molecules and biologics, PK/TK, immunogenicity, IND/CTA and NDA/BLA filings, cross-functional collaboration with Clinical Pharmacology, Data Science, and Regulatory. WorkSetup: hybrid in NYC or Boston; relocation preferred.