Senior Director Toxicology

Position Summary

We are seeking an experienced and strategic Senior Director of Toxicology to lead the nonclinical safety function for our growing oncology pipeline. This individual will provide scientific and regulatory leadership across all toxicology activities supporting clinical development programs, with a primary focus on advancing assets through Phase II and beyond.

Reporting to the Chief Development Officer or Head of Nonclinical Development, the Senior Director will serve as the toxicology subject matter expert, driving the design, execution, interpretation, and regulatory positioning of nonclinical safety studies. The ideal candidate will have deep expertise in oncology drug development, extensive experience supporting INDs and global regulatory interactions, and a proven ability to work cross functionally within a fast paced biotechnology environment.

This is a highly visible leadership role requiring strong scientific judgment, strategic thinking, and the ability to influence development decisions across research and clinical teams.

Key Responsibilities

Nonclinical Safety Strategy

• Develop and execute integrated toxicology strategies to support oncology programs from late discovery through clinical development.
• Provide scientific leadership for all nonclinical safety assessments, including:
• GLP toxicology studies
• Safety pharmacology
• Genotoxicity studies
• Reproductive and developmental toxicology assessments
• Carcinogenicity planning as applicable
• Evaluate safety risks and establish translational strategies to support clinical dosing and risk mitigation.
• Partner closely with Clinical Development, Regulatory Affairs, Pharmacology, DMPK, CMC, and Research teams to align nonclinical safety plans with overall program objectives.

Study Oversight and Data Interpretation

• Design, oversee, and monitor outsourced toxicology studies conducted at CRO partners.
• Review protocols, study reports, pathology findings, and toxicokinetic data.
• Interpret toxicology findings and communicate implications to project teams and senior leadership.
• Ensure studies are conducted according to regulatory expectations and development timelines.

Regulatory Leadership

• Author and review nonclinical sections of regulatory submissions, including:
• INDs
• IBs
• Annual reports
• CTAs
• NDA/BLA supporting documents
• Serve as the toxicology representative during interactions with FDA, EMA, and other global health authorities.
• Provide strategic guidance on regulatory requirements and evolving nonclinical safety expectations.

Cross Functional Leadership

• Represent toxicology on governance committees and development teams.
• Influence portfolio decisions through data driven risk assessments and safety evaluations.
• Mentor and develop junior scientists and external consultants as the organization grows.
• Build and maintain strong relationships with external CROs, consultants, and key opinion leaders.

Vendor Management

• Select and manage external toxicology vendors and pathology experts.
• Oversee budgets, timelines, and quality standards for outsourced studies.
• Ensure efficient resource utilization and successful delivery of program milestones.

Qualifications

Required

• PhD, DVM, PharmD, or equivalent advanced degree in Toxicology, Pathology, Pharmacology, or related life sciences discipline.
• 12+ years of industry experience in nonclinical safety and toxicology within biotechnology or pharmaceutical organizations.
• Significant experience supporting oncology drug development programs.
• Demonstrated success advancing programs through IND enabling studies and clinical development.
• Strong knowledge of ICH, FDA, EMA, and global regulatory requirements related to nonclinical safety.
• Experience managing CRO relationships and outsourced toxicology programs.
• Excellent communication and leadership skills with the ability to influence cross functional teams.