Senior Director, Toxicology

Keros Therapeutics•Lexington, MA

7d•$258,000 - $303,000

About The Position

The Senior Director of Toxicology will serve as the strategic and technical lead for nonclinical safety and efficacy evaluation of Keros’s biologic therapies. The role leads toxicology programs from early discovery through clinical development and global regulatory submissions, including IB, IND, CTA, and BLA submissions. As a subject-matter expert, this position guides cross-functional teams, manages external CROs, and represents toxicology in meetings with global regulatory agencies. The role identifies and addresses safety issues and communicates findings to project teams and company leadership. It reports to the Chief Scientific Officer. Keros develops therapies focused on modulating TGF-β superfamily signaling to address disorders associated with dysfunctional signaling. The company’s research targets pathways involved in blood-cell and tissue growth, repair, and maintenance.

Requirements

Experience leading toxicology strategy for successful IND/CTA filings.
DABT certification or a veterinary degree with pathology training.
Deep understanding of biologics toxicology, including immunogenicity, tissue cross-reactivity, species selection, and PK/PD relationships.
Expert knowledge of ICH, FDA, and EMA guidelines governing nonclinical safety testing of biological products.
Strict adherence to GLP standards.
PhD or DVM in Toxicology, Pharmacology, or Pathology and 10+ years of pharmaceutical-industry toxicology experience; or a Master's in Toxicology and 15+ years of experience, with a documented track record of advancing biologics from discovery through late-stage clinical development.

Nice To Haves

Direct experience with BLA/MAA submissions.
Expertise in biologics-related toxicology or developmental and reproductive toxicology.
Demonstrated ability to collaborate effectively in a team environment.

Responsibilities

Design and direct scientifically rigorous nonclinical toxicology and safety pharmacology strategies for biologics, aligned with clinical development goals and regulatory requirements.
Evaluate treatment targets for potential safety concerns during early development.
Develop strategies to mitigate identified safety issues.
Work with regulatory experts to support the transition of biologics into development and First-in-Human trials.
Collaborate with scientific leadership, outsourcing partners, and consultants to design and implement investigative toxicology studies.
Support research and development through well-designed toxicology studies.
Ensure the accuracy, validity, and completeness of scientific information in non-GLP and GLP nonclinical research.
Prepare toxicology-related regulatory documentation, including IND, IB, CTA, and BLA submissions.
Represent the company as its primary toxicology expert in meetings with health authorities.
Communicate critical results, interpretations, and project information to project teams and company leadership.
Manage nonclinical CROs and vendors for specific programs.