Korro Bio, Inc. · 1 month ago
Director, Assay Development & Biomarkers
Cambridge, MA
Full-time
Onsite
Director/Executive
$205K/yr - $246K/yr
10+ years expKorro Bio, Inc. is a biopharmaceutical company focused on developing innovative genetic medicines. They are seeking a strategic Director of Assay Development and Biomarkers to lead the development and implementation of biomarker strategies across all stages of drug development, ensuring effective drug development and personalized medicine strategies.
BiotechnologyHealth CarePharmaceutical
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 the development, optimization, and validation of robust, fit-for-purpose biomarker assays (e.g., 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 use in clinical trials (e.g., 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; provide real-time interpretation to support clinical decisions
Collaborate with biostatistics, bioinformatics, and data science teams for analysis, interpretation, and visualization of biomarker data
Drive partnerships with discovery, clinical, regulatory, commercial, and CDx development functions to ensure continuity and alignment
Manage external vendors, CROs, and diagnostic partners; serve as technical and scientific lead in biomarker-related interactions
Represent biomarker strategy at governance meetings, scientific advisory boards, and regulatory interactions as needed
Support regulatory filings (e.g., INDs, NDAs, CTDs) with biomarker and assay content, including responses to health authority questions
Develop biomarker plans for post-marketing commitments, real-world evidence generation, or CDx lifecycle management
Qualification
Required
MS or PhD in Molecular Biology, Immunology, Pharmacology, or related life sciences discipline
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
Benefits
Medical
Dental
Vision
401(k) retirement plan
Life insurance
A dependent care flexible spending account
A Company-funded health savings account
Free parking
Company
Korro Bio, Inc.
Korro Bio was founded to turn extraordinary scientific insights into life-altering new treatments for patients.
51-200 employees
H1B Sponsorship
Korro Bio, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$277.5MKey Investors
Deep Track CapitalEventideWu Capital
2024-04-18Post Ipo Equity· $70M
2023-11-06IPO
2022-01-05Series B· $116M
Leadership Team
Ram Aiyar
Chief Executive Officer
Todd Chappell
Chief Operating Officer
Recent News
2026-01-09
New Enterprise Associates
2026-01-05
Genetic Engineering News
2025-11-19
Company data provided by crunchbase