Principal Scientist, Translational Medicine

Role: Lead biomarker strategy development within Translational Medicine for neurodegenerative and rare diseases, supporting clinical development and regulatory submissions. Responsibilities: design and implement biomarker assays, generate clinical evidence of target and pathway engagement, contribute to regulatory documents including BLAs and INDs, mentor junior scientists, and communicate complex data. Qualifications: PhD in biochemistry, neurobiology, molecular biology, or pharmacology; 10+ years of industry or academic experience; expertise in biomarker assay development and clinical interpretation; experience with regulatory submissions and health authority interactions. Preferred: experience with rare/orphan diseases, lysosomal storage disorders, natural history studies, and FDA/health authority meetings. HighValue: focus on lysosomal storage, CNS disorders, biomarker qualification for accelerated approval, clinical assay design, and contribution to regulatory filings. Work setup: not specified; likely collaborative environment across discovery and development teams.