Associate Director/Director, Toxicology

Disc Medicine

278d

About The Position

Disc Medicine is searching for a Director of Toxicology with strong expertise in monoclonal antibody analysis. The successful candidate will provide expertise in managing outsourced nonclinical safety studies conducted under both GLP and non-GLP conditions. The successful candidate should also have an understanding of pharmacokinetic data and appropriate justifications for dose selections. This person is expected to interact with cross-functional teams to execute nonclinical studies and work within developmental program teams to provide nonclinical safety assessments, help achieve program goals, and assist in the drafting of regulatory documents.

Requirements

• Ph.D. in toxicology or pharmacology with 10+ years of experience conducting GLP toxicology studies within the pharmaceutical industry
• Understanding global toxicology guidelines, such as ICH, FDA, and EMA
• At least 5+ years of experience with monoclonal antibody drug development
• Planning and execution of IND-enabling studies to support first-in-human studies
• Planning and execution of late-stage nonclinical toxicity studies
• Experience in writing and presenting nonclinical safety data within Common Technical Documents for submission to regulatory authorities (e.g., IND, NDA, MAA)
• Has excellent interpersonal, organizational, and communication 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

Nice To Haves

• Experience with large and small molecules in both early- and late-stage drug development
• Experience in hematology and rare disease drug development
• D.A.B.T certification

Responsibilities

• Manage outsourced GLP toxicology and safety pharmacology work
• Identify and work with CROs to oversee budgets, timelines, protocol designs, study monitoring, and drafting of study reports
• Visit GLP testing sites to review facilities and capabilities for the conduct of studies
• Review, analyze, and summarize nonclinical safety data for internal presentations and regulatory filings
• Draft relevant toxicology sections of regulatory documents (e.g., IND, IB, IMPD, BLA, NDA, etc.)
• Represent toxicology at cross-functional teams to provide safety information to assist in internal decisions and regulatory filings

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree