Principal Scientist, Biomarker Bioanalytical Sciences

Role: Principal Scientist leading bioanalytical and biomarker strategies supporting discovery through clinical development within the Biomarkers and Systems Biology group. Responsibilities: serve as bioanalytical lead, develop and validate assays (PK, ADA, TE, PD, Disease), oversee CRO activities, review data, troubleshoot, and ensure regulatory compliance; interpret bioanalytical data and support regulatory submissions (IND, CTA, BLA); evaluate emerging biomarker technologies and ensure assay robustness and data integrity. Requirements: PhD or MS in Immunology, Molecular Biology, or related field; PhD with 5+ years or MS with 8+ years industry experience; expertise in biomarker and bioanalytical assay development, validation, and supporting clinical programs; proven CRO oversight and regulatory documentation experience; strong scientific communication skills. Preferred: experience in clinical biomarker programs, publication record, and defending bioanalytical content for regulatory filings. HighValue: bioanalytical assay development, biomarker strategies, regulated bioanalysis, clinical-stage support, IND/CTA/BLA contributions, cross-functional collaboration, and external vendor management. WorkSetup: not specified; likely office-based with external interactions.