Associate Director – Toxicology

Role Overview

• Lead the design, execution, and interpretation of GLP and non-GLP toxicology studies to support target assessment, platform innovation initiatives, development candidate selection, and regulatory submissions.
• Serve as the toxicology subject matter expert on cross-functional program teams, contributing to overall project strategy and decision-making.
• Develop and implement nonclinical safety strategies specific to oligonucleotide therapeutics, including considerations for sequence, chemistry, delivery, and off-target effects.
• Experience designing, outsourcing, and overseeing nonclinical toxicology studies at external CROs, including international vendors; prior experience working with CROs in China (or broader APAC region) is highly desirable. Mandarin language skills are a plus, particularly for candidates with experience working with China based CROs.
• Ensure high-quality execution of all external safety studies and timelines, including general toxicology, safety pharmacology, genetic toxicology, and immunotoxicology as needed.
• Prepare reports and presentations for internal and external audiences.
• Prepare and review regulatory documentation, including INDs, CTAs, Investigator’s Brochures, and responses to health authority queries.
• Author and/or oversee preparation of nonclinical sections for regulatory submissions across the product lifecycle, including INDs and later-stage filings (NDA/BLA), with responsibility for Module 2 summaries, study reports, and health authority responses.
• Contribute to regulatory strategy and agency interactions, with experience with accelerated development pathways and/or rare disease programs being highly desirable.
• Represent Korro in regulatory interactions, including pre-IND and other milestone meetings.
• Stay current on regulatory guidelines, safety assessment trends, and emerging science relevant to oligonucleotide and RNA-based therapies.
• Mentor and develop junior scientists and contribute to a culture of scientific rigor, collaboration, and innovation.

Requirements

• PhD, DVM, or equivalent in toxicology, pharmacology, or related field; board certification (e.g., DABT) strongly preferred.
• 6-10+ years of relevant industry experience in toxicology, with a strong track record of supporting mechanistic toxicology and IND-enabling programs.
• Deep knowledge of global regulatory expectations, ICH guidelines, and GLP principles.
• Strong leadership, communication, and organizational skills, with the ability to work effectively in a fast-paced, matrixed environment.
• Proven ability to influence across functions and effectively interface with both internal and external stakeholders.

Benefits

• Korro offers competitive compensation
• Equity-based compensation
• Comprehensive benefits package
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Dependent care flexible spending account
• Company-funded health savings account
• Free parking