Senior Director, Toxicology
D
Disc MedicineBiopharmaceutical
Massachusetts - Hybrid; flexibility to work remotely or from our headquarters in Watertown, MA.Full-TimeDirector
Salary261,000 - 319,000 USD per year
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Job Details
- Experience
- 10-14 years of experience overseeing toxicology programs and conducting GLP toxicology studies within the pharmaceutical industry
Requirements
- Ph.D. in toxicology.
- 10-14 years of experience overseeing toxicology programs and conducting GLP toxicology studies in the pharmaceutical industry.
- Strong understanding of global toxicology guidelines, including ICH, FDA, and EMA.
- Experience planning and executing IND-enabling studies to support first-in-human studies.
- Experience planning and executing late-stage nonclinical toxicity studies.
- Expertise writing and presenting nonclinical safety data in Common Technical Documents for regulatory submissions, such as IND, NDA, and MAA.
- Experience with cross-functional interactions in matrix teams.
- Preferred: experience with large and small molecule drug development and hematology and rare disease drug development.
- Preferred: D.A.B.T. certification.
- Scientific excellence evidenced by publications in scientific journals and/or presentations at scientific conferences.
Responsibilities
- Design, execute, and interpret nonclinical safety studies across drug development, including GLP toxicology, reproductive toxicology, carcinogenicity, and safety pharmacology.
- Use pharmacokinetic data to justify toxicology study doses and selection of safe and effective clinical doses.
- Oversee study budgets, timelines, and monitoring, and visit GLP testing sites to review facilities and capabilities.
- Partner with clinical development, technical operations, DMPK/clinical pharmacology, discovery, and program teams.
- Present interpretations of nonclinical safety data and toxicology strategy to cross-functional teams.
- Draft toxicology sections of regulatory documents, including IND, IB, IMPD, BLA, and NDA submissions.
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