Senior Director, Toxicology

The role

The Senior Director, Toxicology will lead nonclinical safety assessments and drive toxicology strategy across the portfolio. This role provides safety expertise from early-stage discovery and IND-enabling studies through to global market authorizations.

What you will do

• Design, execute, and interpret nonclinical safety studies including GLP toxicology, reproductive toxicology, carcinogenicity, and safety pharmacology.
• Use pharmacokinetic data to establish scientific justifications for toxicology study dose justifications and clinical doses.
• Oversee budgets, timelines, and study monitoring.
• Visit GLP testing sites to review facilities and capabilities.
• Partner with clinical development, technical operations, DMPK/clinical pharmacology, discovery, and program teams.
• Provide concise presentations on data interpretation and strategy.
• Draft relevant toxicology sections of regulatory documents such as IND, IB, IMPD, BLA, and NDA.

Required qualifications

• D. in toxicology
• 10-14 years of experience overseeing toxicology programs and conducting GLP toxicology studies within the pharmaceutical industry
• Strong understanding of global toxicology guidelines, such as ICH, FDA, and EMA
• Planning and execution of IND-enabling studies to support first-in-human studies
• Planning and execution of late-stage nonclinical toxicity studies
• Strong expertise in writing and presenting nonclinical safety data within Common Technical Documents for submission to regulatory authorities
• Excellent interpersonal, organizational, and communication skills
• Great collaboration and teamwork skills
• Experience in cross-functional interactions in matrix teams
• Track record of scientific excellence in toxicology or related scientific areas evidenced by publications or presentations

Nice to have

• Experience with both large and small molecule drug development
• Experience in hematology and rare disease drug development
• D.A.B.T certification

Benefits

• Comprehensive benefits
• Competitive compensation packages
• Flexible work environment

About the company

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. The company targets fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis.