The Director of Toxicology is accountable for timely and effective drug safety support for programs in non-clinical and clinical development. The incumbent is expected to support non-clinical development through the design, management and regulatory submissions of all non-clinical safety studies for the company’s drug development programs, as well as provide expertise and guidance in Regulatory Toxicology to project teams and management. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The incumbent will be an active participant on project/program teams, and will work closely with other functional areas such as Discovery Biology, Pharmacology, Medicinal Chemistry, DMPK, CMC and Clinical. The incumbent will manage contracts and budgets and provide study monitoring for outsourced GLP toxicology studies and will provide appropriate content and submission-ready documentation for the toxicology components of regulatory submissions.
- Design, manage, analyze, review, summarize, interpret and report results of Toxicology and Safety Pharmacology studies.
- Review and approve Toxicology study protocols, reports, associated nonclinical summaries, Regulatory submission sections and associated documentation, as well as abstracts/manuscripts for publication.
- Provide high-level advice to project/program teams and senior management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy.
- Maintain up-to-date Toxicology plans (linked to overall development plan) for all projects/programs/products, including listings of studies, timelines, status, and costs; update and refine as necessary.
- Provide strategic preclinical expertise to cross-functional teams as the in-house toxicology/safety expert.
- Prepare for and participate in regulatory agency interactions.
- PhD in a related subject, with DABT certification preferred, but not required.
- 10+ years industry-related experience in regulatory Toxicology working within the pharmaceutical industry.
- Hands-on experience in all aspects of Toxicology study conduct including general, genetic, developmental, and reproductive toxicology, toxicokinetics, and safety pharmacology.
- Experience with pre-IND through Phase 1-3 programs and associated regulatory filings.
- Demonstrated knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, ICH and other applicable global guidelines.
- Experience in the outsourcing and external oversight of nonclinical Toxicology studies conducted by qualified CROs.
- Experience in working with U.S. and European regulatory authorities.
- Excellent communication and presentation skills.