Director, Assay Development & Biomarkers
Company: Korro Bio
Location: Cambridge
Posted on: February 18, 2026
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Job Description:
Job Description Job Description Company Summary: Korro is a
biopharmaceutical company focused on developing a new class of
genetic medicines for both rare and highly prevalent diseases using
its proprietary RNA editing platform. Korro is generating a
portfolio of differentiated programs that are designed to harness
the body’s natural RNA editing process to effect a precise yet
transient single base edit. By editing RNA instead of DNA, Korro is
expanding the reach of genetic medicines by delivering additional
precision and tunability, which has the potential for increased
specificity and improved long-term tolerability. Using an
oligonucleotide-based approach, Korro expects to bring its
medicines to patients by leveraging its proprietary platform with
precedented delivery modalities, manufacturing know-how, and
established regulatory pathways of approved oligonucleotide drugs.
Korro is based in Cambridge, Massachusetts. We are collaborative
and united by a common mission. We are building a company with
extraordinary people with an audacious vision to create
transformative genetic medicines for prevalent diseases. Our values
- Rewrite the future, On the Cutting Edge, Better Together,
Dynamically Different, Kindness and Integrity form the fabric of
the organization. They are reinforced daily and serve as key
dimensions in the hiring process to help us ensure that Korro is a
magnet for outstanding talent and a great place to work. Join us as
we redefine what's possible in genetic medicine and work to make a
lasting impact on human health. 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 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. Required
Qualifications: 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: Korro
offers competitive compensation, including equity-based
compensation, and a comprehensive benefits package that includes
medical, dental, vision, 401(k) retirement plan, life insurance, a
dependent care flexible spending account and a Company-funded
health savings account and free parking. We may use artificial
intelligence (AI) tools to support parts of the hiring process,
such as reviewing applications, analyzing resumes, or assessing
responses. These tools assist our recruitment team but do not
replace human judgment. Final hiring decisions are ultimately made
by humans. If you would like more information about how your data
is processed, please contact us.
Keywords: Korro Bio, New Britain , Director, Assay Development & Biomarkers, Science, Research & Development , Cambridge, Connecticut
