Korro Bio, Inc.

Compliance

• Serve as the strategic and operational leader responsible for developing and executing global regulatory strategies to support clinical development, registration, and commercialization of the company’s pipeline
• Provide leadership and direction to internal teams and external partners, ensuring regulatory compliance and fostering effective interactions with global health authorities
• Report to the Chief Scientific Officer and work in close partnership with the VP of Clinical Operations, VP of Clinical Development, and VP Research & Preclinical
• Develop and implement global regulatory strategies aligned with corporate objectives for preclinical, clinical, and commercial programs
• Lead preparation and submission of INDs/CTAs, BLAs/NDAs/MAAs, and other key filings
• Anticipate and mitigate regulatory risks; provide proactive guidance on evolving regulatory landscapes
• Oversee all regulatory submissions, ensuring completeness, accuracy, and compliance with applicable regulations
• Manage regulatory documentation systems and ensure inspection readiness
• Lead interactions with external consultants, CROs, and regulatory agencies
• Partner closely with Clinical Development, CMC, Nonclinical, and project teams to align regulatory strategies with development plans
• Serve as a trusted advisor to senior leadership on regulatory implications of corporate decisions

Senior Director – Regulatory Affairs

Machine Learning Engineer

• Drive research and development of novel deep learning architectures, training paradigms (e.g., supervised, self-supervised, generative, multi-modal), and algorithms tailored for large-scale biological sequence data and related modalities.
• Partner with computational biologists, data scientists, and data engineers to integrate domain expertise, define scientifically meaningful tasks, and apply cutting-edge machine learning research towards ambitious biological challenges.
• Design, implement, and maintain robust ML Operations (MLOps) pipelines for model training, evaluation, versioning, and deployment using cloud-based infrastructure and tools like AWS's MLflow.
• Design and execute statistically rigorous experiments using design of experiments (DOE), A/B testing, and Bayesian approaches to optimize RNA editing strategies, validate model predictions, and advance our mechanistic understanding of RNA editing through testable biological hypotheses.
• Identify and prototype novel machine learning applications across diverse organizational functions including manufacturing optimization, supply chain analytics, regulatory strategy, and clinical trial design.
• Mentor early career scientists and engineers, fostering a culture of technical excellence and scientific curiosity through leadership and code review.
• Contribute to long-term strategic planning for ML/AI platform capabilities, identifying emerging technologies and research directions that could transform genetic medicine development timelines and outcomes.
• Share research findings through internal presentations and contribute to the scientific community via publications or presentations.

Senior Scientist, Machine Learning, Drug Development

Director

• Manage investigational products supporting clinical development pipeline and studies, ensuring on-time delivery of study drug to participants and overall clinical supply chain management (packaging, labeling, distribution, inventory management, returns, and destruction of IMP/CTM)
• Develop clinical forecast / demand plans based on trial requirements; identify supply chain risks and implement mitigation plans
• Work with cross-functional teams to define clinical supply plans and provide clinical supply status reports
• Review clinical protocols for study supply requirements and contribute to study drug packaging design
• In collaboration with quality, create label text in compliance with regulations and manage translations and country-specific requirements
• Manage vendors for labeling, packaging, and global distribution of investigational product and ancillary supplies
• Develop IRT (IXRS) supply and return strategy, lead IRT/IXRS setup, and participate in User Acceptance Testing
• Manage evaluation of temperature excursions and cold-chain logistics
• Develop requirements/specifications for clinical study drug and other drug supply, including packaged product, shipping and storage specifications
• Contribute to study-specific pharmacy manuals and supply-related training/instructional materials
• Coordinate with Supply Chain for use of commercial products in clinical environment
• Stay current on Korro SOPs related to CTM/IMP distribution and follow procedures for release of IMP to clinical sites
• Develop clinical supply budget and forecasting and track invoices to contracts
• Provide Regulatory Affairs with applicable information or sections for IND/IMPD/CTA/etc. submissions
• Report to VP Clinical Operations and interact with Technical Operations, Clinical Development, Quality, Regulatory, and external vendors

Associate Director, Clinical Supply

• 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