POSITION OVERVIEW:

Disc Medicine is seeking an experienced, strategic Senior Director, Toxicology to join our team. Reporting directly to the Vice President, Head of Toxicology, the successful candidate will play a pivotal role in leading nonclinical safety assessments and driving toxicology strategy across the Disc portfolio. The successful candidate will provide critical safety expertise from early-stage discovery and IND-enabling studies through to global market authorizations. The ideal candidate will also blend deep technical knowledge in nonclinical safety and pharmacokinetics with strong communication skills to cross-functionally guide programs toward clinical success.

RESPONSIBILITIES:

• Design, execute, and interpret nonclinical safety studies across all phases of drug development, including GLP toxicology, reproductive toxicology, carcinogenicity, and safety pharmacology work.
• Sound background and understanding of pharmacokinetic data to establish appropriate scientific justifications for toxicology study dose justifications and selection of safe and effective clinical doses.
• Oversight of budgets, timelines, and study monitoring and willing to visit GLP testing sites to review facilities and capabilities.
• Partner closely with clinical development, technical operations, DMPK/clinical pharmacology, discovery, and program teams to provide concise presentations on data interpretation and strategy.
• Knowledge of nonclinical regulatory frameworks and ability to draft relevant toxicology sections of regulatory documents (e.g., IND, IB, IMPD, BLA, NDA, etc.).

 REQUIREMENTS:

• D. in toxicology with 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 (e.g., IND, NDA, MAA)
• Possesses 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 in scientific journals and/or presentations at scientific conferences

PREFERRED QUALIFICATIONS:

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