Korro Bio, Inc.

Director, Assay Development and Biomarkers

Korro Bio, Inc.

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Job Level

Lead

About the role

  • 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

Requirements

  • PhD in Molecular Biology, Immunology, Pharmacology, or related life sciences discipline; MD or MD/PhD preferred
  • Therapeutic area experience in Liver Diseases, Neurological Disorders, or Rare Diseases
  • 10+ years of experience in biomarker research, translational science, or assay development within the biotech/pharma industry
  • Proven experience with biomarker strategy and assay development across discovery, clinical, and commercial stages
  • Demonstrated success working with regulatory agencies on biomarker and CDx-related filings
  • Experience managing CROs and external diagnostic partners
  • Deep knowledge of a broad range of assay platforms and technologies
  • Familiarity with GLP/GCLP, CLIA, and regulatory requirements for biomarker assays
  • Strong understanding of genomics, proteomics, and data integration
  • Proven leadership in cross-functional matrix environments
  • Excellent written and verbal communication skills, including scientific presentation and regulatory writing experience
  • Strategic thinker with operational excellence and scientific rigor