Senior Director – Toxicology
| Company | Korro Bio |
|---|---|
| Location | Cambridge, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | PhD, MD |
| Experience Level | Expert or higher |
Requirements
- PhD, DVM, or equivalent in toxicology, pharmacology, or related field; board certification (e.g., DABT) strongly preferred.
- 10+ years of relevant industry experience in toxicology, with a strong track record of supporting IND-enabling programs.
- Hands-on experience with oligonucleotide-based therapeutics is a plus.
- Familiarity with lipid nanoparticles (LNPs) or other delivery systems is a plus.
- 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 both internal and external stakeholders.
Responsibilities
- Lead the design, execution, and interpretation of GLP and non-GLP toxicology studies to support 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.
- Oversee CROs to ensure high-quality execution of 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.
- 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.
Preferred Qualifications
- Hands-on experience with oligonucleotide-based therapeutics is a plus.
- Familiarity with lipid nanoparticles (LNPs) or other delivery systems is a plus.