Senior Director, Biologics Toxicology & Regulatory Strategy

Keros Therapeutics Inc.; Lexington (MA); On-site; USD 258,000 - 303,000; Full time

Job summary

Keros Therapeutics is seeking a Senior Director of Toxicology to lead nonclinical safety and efficacy assessment across a biologics-focused pipeline. You will guide toxicology programs from discovery to regulatory submissions, supervise CROs, and serve as the primary toxicology expert in regulatory discussions.

The role requires hands-on leadership of toxicology strategy, strong regulatory experience, and collaboration with cross-functional teams to ensure safety and timely development

Qualifications

• Proven experience leading non-clinical toxicology strategy for IND/CTA filings.
• Deep knowledge of biologics toxicology, immunogenicity, TCR and PK/PD.
• Strong understanding of ICH/FDA/EMA GLP guidelines for non-clinical testing.

Responsibilities

• Design and direct non-clinical toxicology strategies for biologics.
• Lead safety evaluations and develop mitigation plans.
• Collaborate with regulatory teams to support regulatory submissions (IND/IB/CTA/BLA).
• Represent toxicology in meetings with health authorities.
• Manage external CROs and vendor relationships for programs.
• Ensure accuracy and completeness of non-clinical data and reports.
• Prepare regulatory documentation for toxicology studies (IND/IB/CTA/BLA).
• Communicate results and implications to project teams and leadership.

Skills

Toxicology strategy

IND/CTA filings

BLA/MAA submissions

DABT certification

GLP compliance

Biologics toxicology

Education

PhD or DVM in Toxicology

MS in Toxicology (15+ yrs)

Job description

Keros Therapeutics is seeking a Senior Director of Toxicology to lead nonclinical safety and efficacy assessment across a biologics-focused pipeline. You will guide toxicology programs from discovery to regulatory submissions, supervise CROs, and serve as the primary toxicology expert in regulatory discussions.

The role requires hands-on leadership of toxicology strategy, strong regulatory experience, and collaboration with cross-functional teams to ensure safety and timely development