Senior Director, Toxicology

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

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.

Job Summary

The Senior Director of Toxicology will serve as the strategic and technical lead for nonclinical safety and efficacy evaluation of a growing pipeline of innovative biologic therapies. You’ll lead toxicology programs from early discovery through clinical development and global regulatory submissions (IB, IND, CTA, BLA). As a primary subject-matter expert, you will guide cross-functional teams, manage external CROs, and serve as the face of toxicology for global regulatory agencies. Your expertise will be essential for identifying safety issues, collaborating with regulatory experts, and communicating critical results to project teams and company leadership. This position reports into to the Chief Scientific Officer.

Primary Responsibilities

• Design and direct comprehensive, scientifically rigorous non-clinical toxicology and safety pharmacology strategies tailored specifically for biologics (e.g., mAbs, bispecifics, fusion proteins, and novel modalities, ensuring alignment with clinical development goals and regulatory requirements.
• Conduct safety evaluations on treatment targets during early stages to proactively detect potential safety concerns.
• Develop mitigation strategies to address safety issues.
• Work closely with regulatory experts to facilitate the smooth transition of biologics into development and First-in-Human (FIH) trials.
• Collaborate with scientific leadership, strategic outsourcing partners, and consultants to design and implement investigative toxicology studies.
• Support research and development efforts through well-designed toxicology studies.
• Ensure the accuracy, validity, and completeness of scientific information in non-GLP and GLP non-clinical research.
• Prepare regulatory documentation related to toxicology studies (e.g., IND, IB, CTA, BLA, submissions).Represent the company as the primary toxicology expert in meetings with health authorities.
• Communicate critical results, interpretations, and project information to various stakeholders, including project teams and company leadership.
• Manage nonclinical Contract Research Organizations (CROs) and vendor management for specific programs.

Required Skills

• Proven experience leading the toxicology strategy for successful IND/CTA filings; direct experience with BLA/MAA submissions is strongly preferred.
• DABT certification or veterinary degree with pathology training.
• Deep understanding of the unique challenges of biologics toxicology, including immunogenicity, tissue cross-reactivity (TCR), species selection, and PK/PD relationships.
• Expert knowledge of ICH, FDA, and EMA guidelines governing the non-clinical safety testing of biological products, alongside strict adherence to GLP standards.

Preferred Skills

• Expertise in either Biologics-related toxicology or developmental and reproductive (DART)-related toxicology
• Demonstrated ability to collaborate effectively in a team environment

Education Requirements

PhD or DVM in Toxicology, Pharmacology, Pathology with 10+ years of toxicology experience in the pharmaceutical industry, or Master's in Toxicology with 15+ years of experience with a documented track record of successfully advancing biologics from discovery through late-stage clinical development This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.

Potential base pay range

$258,000 — $303,000 USD

Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.

Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Recruitment & Staffing Agencies:

Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.