Job Description

Disc Medicine seeks an experienced Senior Director of Toxicology to lead nonclinical safety assessments and toxicology strategy across its hematology drug portfolio. The role combines technical expertise in preclinical safety evaluation with cross-functional leadership, spanning from early discovery through regulatory approval in a hybrid Massachusetts-based position.

Responsibilities

• Design, execute, and interpret nonclinical safety studies across all development phases
• Establish dose justifications and safe clinical doses using pharmacokinetic data
• Oversee toxicology study budgets, timelines, and conduct site monitoring visits
• Collaborate with clinical, technical, and discovery teams on safety strategy and data interpretation
• Draft toxicology sections of regulatory documents for IND and market authorization submissions

Requirements

• Ph.D. in toxicology with 10-14 years of pharmaceutical industry experience
• Expertise in GLP toxicology, reproductive toxicology, carcinogenicity, and safety pharmacology studies
• Knowledge of ICH, FDA, and EMA global toxicology guidelines
• Experience planning IND-enabling and late-stage nonclinical toxicity studies
• Proficiency writing nonclinical safety sections for regulatory submissions (IND, NDA, MAA)
• Strong presentation and cross-functional communication abilities
• Track record of scientific publications or conference presentations

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