Associate Director, Toxicology

Role Summary

As the Associate Director of Toxicology, you will play a critical role in advancing our innovative drug discovery and development programs by providing expert guidance and hands-on toxicology and safety pharmacology support. You will design and manage non-clinical safety studies, provide strategic input to project teams, and ensure high standards of scientific and ethical conduct. You will collaborate across Discovery Biology, Pharmacology, Medicinal Chemistry, DMPK, CMC and Clinical teams, oversee contracts, budgets, and CRO relationships for outsourced toxicology studies, and prepare submission-ready regulatory documentation.

Responsibilities

• Apply your extensive toxicology expertise to design, manage, analyze, interpret and report on safety pharmacology and toxicology studies, including general toxicology, genetic toxicology, developmental & reproductive toxicology (DART), as well as toxicokinetics.
• Draft, review and approve toxicology study protocols, reports, associated nonclinical summaries, regulatory submission sections and associated documentation, as well as abstracts/manuscripts for publication
• Provide strategic toxicological assessments and preclinical guidance to project teams and senior management to inform key program decisions and clinical/regulatory strategies
• Oversee contracts, budgets and CRO relationships for outsourced toxicology/safety pharmacology studies to ensure the highest standards of scientific and ethical conduct
• Maintain up-to-date toxicology plans for all IND and NDA enabling projects/programs including listings of studies, timelines, status, and costs; update and refine as necessary.
• Assess the risk of drug candidates on reproductive health, particularly in relation to exposure levels and durations
• Leverage your regulatory expertise to provide high-quality, submission-ready documentation for interactions with health authorities

Qualifications

• PhD in Toxicology or related health discipline with 7+ years of industry-related experience in regulatory toxicology in the conduct of regulatory submissions; DABT certification a plus
• Extensive hands-on experience in all facets of toxicology study conduct with a proven track record of conducting preclinical drug safety assessments; an emphasis on developmental and reproductive toxicology is a plus
• Experience in outsourcing and external oversight of nonclinical toxicology studies conducted by qualified CROs
• Deep knowledge of global regulatory requirements for non-clinical safety packages across all phases of development; Experience in working with U.S. and European regulatory authorities
• Excellent communication skills to present complex scientific information to diverse audiences and author regulatory documents and scientific publications
• Ability to make risk assessments and represent toxicology perspectives on project teams and with external partners