Position Summary
The Director, Toxicology provides scientific leadership for nonclinical safety assessment activities supporting oncology drug development. This role is responsible for toxicology study strategy, data interpretation, risk assessment, and regulatory support, while partnering with cross-functional teams to advance programs from discovery through clinical development.
Key Responsibilities
- Develop and implement nonclinical toxicology strategies for oncology programs.
- Serve as the toxicology subject matter expert, providing safety assessments and development recommendations to project teams.
- Design, oversee, and interpret nonclinical safety studies, including acute, chronic, reproductive/developmental, genotoxicity, and carcinogenicity assessments.
- Integrate nonclinical, clinical, mechanistic, and exposure data to support scientifically sound conclusions and risk assessments.
- Evaluate safety margins, characterize potential risks, and provide benefit-risk recommendations to support development decisions.
- Author and review toxicology content for INDs, CTAs, Investigator's Brochures, and other regulatory submissions.
- Support interactions with regulatory authorities and ensure compliance with FDA, EMA, ICH, and other applicable guidelines.
- Collaborate with Clinical, Regulatory, Pharmacology, DMPK, and other functional teams to advance oncology programs.
- Manage external CROs, consultants, and toxicology studies to ensure quality, timelines, and regulatory compliance.
- Present toxicology findings and recommendations to senior leadership and other key stakeholders.
Requirements
- Advanced degree: PhD, DVM, or equivalent advanced degree in toxicology, pharmacology, or a closely related scientific discipline.
- Board certification: Current board certification in toxicology, typically Diplomate of the American Board of Toxicology (DABT) or an equivalent recognized credential.
- Professional experience: 5+ years of relevant toxicology experience in pharmaceutical industry or relevant regulatory agency
- Study design and interpretation: Ability to design toxicology studies to meet regulatory standards and critically evaluate data, including acute, subchronic, chronic, reproductive/developmental, genotoxicity, carcinogenicity, and other relevant endpoints.
- Data analysis: Ability to integrate animal, human, in vitro, in silico, exposure, and mechanistic data to develop scientifically defensible conclusions.
- Toxicological risk assessment: Demonstrated expertise in hazard identification, dose-response assessment, exposure assessment, and human health risk characterization.
- Regulatory experience: Strong understanding of toxicology regulations, standards, and guidance from agencies such as FDA, EMA, or other relevant regulatory authorities.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
