Korro Bio, Inc.

Director

• Position Summary: We are seeking an experienced and strategic Director, Assay Development and Biomarkers to lead and drive the development, validation, and implementation of biomarker strategies and associated assays across all stages of drug development
• Company Summary: Korro is a biopharmaceutical company developing a new class of genetic medicines using a proprietary RNA editing platform, based in Cambridge, Massachusetts
• Key Responsibilities: Develop and execute biomarker strategies aligned with program objectives across all development stages (preclinical, clinical, regulatory, and commercial)
• Define and prioritize biomarker hypotheses (PD, prognostic, predictive, safety, response) and guide integration into study designs
• Provide expert input into translational and clinical development plans, including end-to-end biomarker plans for IND, CTA, and NDA/MAA submissions
• Lead development, optimization, and validation of fit-for-purpose biomarker assays (IHC, ELISA, PCR, NGS, flow cytometry, mass spectrometry, multiplex platforms)
• Oversee internal or outsourced assay development and qualification for exploratory clinical trial use (CLIA/CAP, GCLP), and companion diagnostics (IVD)
• Ensure assay readiness and quality for clinical trials (sample logistics, CRO/vendor oversight, SOPs, assay tech transfer)
• Partner with scientists, clinical teams, and regulatory leads to integrate biomarkers into clinical trial protocols and endpoints
• Monitor biomarker data in ongoing studies and provide real-time interpretation to support clinical decisions
• Collaborate with biostatistics, bioinformatics, and data science teams for analysis, interpretation, and visualization of biomarker data
• Manage external vendors, CROs, and diagnostic partners and represent biomarker strategy at governance meetings and regulatory interactions