Toxicology Director

Key Responsibilities

• Develop and lead nonclinical toxicology and safety pharmacology strategies across multiple development programs.
• Design, oversee, and interpret GLP and non-GLP toxicology studies conducted through external CRO partners.
• Provide scientific leadership for IND-enabling studies and regulatory submissions.
• Audit toxicological risks and support decision-making throughout the drug development process.
• Collaborate closely with Discovery, DMPK, Clinical Development, Regulatory Affairs, and Project Leadership teams.
• Author and review toxicology sections of regulatory documents, including INDs, IBs, briefing packages, and responses to health authorities.
• Represent toxicology and nonclinical safety during interactions with regulatory agencies.
• Manage external vendors and ensure studies are delivered on time, within budget, and to the highest scientific standards.
• Mentor and develop internal scientific staff while contributing to the growth of the nonclinical development function.

What you'll need

• PhD, DVM, PharmD, or equivalent advanced degree in Toxicology, Pharmacology, Veterinary Sciences, or a related scientific discipline.
• 10+ years of industry experience within pharmaceutical, biotechnology, or CRO environments.
• Demonstrated expertise in nonclinical toxicology and safety assessment supporting drug development programs.
• Strong knowledge of FDA, EMA, ICH, and GLP regulatory requirements.
• Experience supporting IND submissions and regulatory interactions.
• Proven ability to lead cross-functional teams and influence program strategy.