Associate Director/Director, Toxicology

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’s lead program is Alpha-1 Antitrypsin Deficiency (AATD). 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.

Overview

Overview The Associate Director/Director, Toxicology, is a key member of the preclinical development team, reporting to the Vice President of preclinical development. In this role, you will be accountable for the GLP tox studies that support regulatory filings and exploratory tox studies to support Korro discovery programs. You will also author nonclinical sections in regulatory submission documents, and address regulatory inquiries. Furthermore, you will represent toxicology at cross-functional project teams and design nonclinical safety data package for Korro programs.  

• Additional representative responsibilities will include, but not necessarily be limited to, the following:
• Design, monitor, and report the IND/CTA toxicology enabling studies, including GLP tox, safety phram, genotox studies, etc. 
• Act as the primary representative for toxicology at cross-functional project teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall development strategy and timeline of candidate molecules.
• Provide strategic direction on toxicology from discovery throughout market application for programs in different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.
• Provide scientific guidance on study design, execution, and interpretation of nonclinical safety data; and oversee nonclinical safety studies outsourced to contract research organizations.
• Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on Program and Clinical/Regulatory strategy.
• Author nonclinical sections in regulatory submission documents (e.g., IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, Scientific Advice, annual reports, and briefing documents).
• Contribute to issue-resolution teams, driving the scientific approach for toxicology issue resolution.
• Provide impurity safety assessment in support of CMC manufacturing and/or registration.
• Contribute to department SOPs and best practice documents.

• DVM, Ph.D., or equivalent in Toxicology or a related discipline. DABT/DACVP certification preferred.
• 7-10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a regulatory authority.
• Proven track record of successfully leading toxicology programs through various stages of drug development.
• Experience in toxicology on oligonucleotides, biologics is a plus.
• Comprehensive knowledge of GLP regulations and all regulatory guidance related to the nonclinical evaluation.
• Passion for science with strong strategic thinking, critical thinking, and leadership skills.
• Agility to adapt to changes and flexibility to work across different time zones.
• Excellent interpersonal and communication skills.

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.