Director, Bioassay Development

Role: Director of Bioassay Development within Technical Operations at Denali Therapeutics, leading the bioassay function for protein biologics across development stages. Responsibilities: provide strategic and technical leadership in potency and impurity assay development, including assay design, qualification, validation, transfer, and lifecycle management; mentor and grow a team of scientists; collaborate with cross-functional teams (Process Development, QC, QA, Regulatory, Translational Sciences, external partners) to support clinical, regulatory, and commercial milestones; establish and oversee assay control strategies and troubleshooting. Requirements: Ph.D. in biochemistry, molecular or cell biology with 10+ years biotech/pharma experience, including 8+ years in leadership; deep expertise in biologics potency assays (ligand-binding, cell-based, enzyme activity, reporter assays), assay qualification, validation, and GMP compliance; experience with complex biologics such as monoclonal antibodies, Fc-fusions, bispecifics; strong knowledge of CMC development, regulatory interactions, assay troubleshooting, and data interpretation. Preferred: prior experience supporting biologics from early clinical to post-market stages, managing multi-disciplinary teams, and authoring regulatory submissions. HighValue: biologics (proteins, antibodies, Fc-fusions), assay development for complex modalities, GMP/CMC focus, cross-functional collaboration, senior leadership, and program lifecycle support. WorkSetup: not explicitly specified.