Director, Translational Bioanalytical Sciences

Role: Director of Translational Bioanalytical Sciences, leading the development, validation, and strategic application of bioanalytical and biomarker assays supporting early to late-stage clinical programs across small molecules, biologics, and emerging modalities. Responsibilities: oversee assay development and validation, collaborate with cross-functional teams (Clinical Pharmacology, Regulatory, Research) to shape biomarker strategies, contribute to regulatory filings (INDs, NDAs), interpret bioanalytical data to inform development decisions, manage external CROs, and provide scientific leadership and mentorship. Requirements: PhD in Analytical Chemistry, Pharmacology, or related field; 10+ years in biopharma supporting translational sciences, bioanalysis, or biomarker research; extensive experience with LC-MS/MS and other advanced bioanalytical technologies; proven leadership in global, matrixed teams; familiarity with regulatory standards (FDA, EMA, ICH); experience managing CRO partnerships. HighValue: support for diverse modalities (small molecules, biologics), clinical development from early to late phases, regulatory interactions, and emphasis on assay validation and biomarker strategy. WorkSetup: hybrid role based in Bridgewater, NJ, with ~10% domestic travel.