Director, Toxicology

Position Overview

The Director, Toxicology provides scientific and strategic leadership for the nonclinical safety assessment of oncology therapeutics from discovery through commercialization. This individual serves as the toxicology lead on multidisciplinary project teams and is responsible for developing scientifically rigorous, phase-appropriate nonclinical safety strategies that enable efficient progression of pipeline assets while meeting global regulatory expectations.  

The Director partners closely with Research, Clinical Development, Translational Science (DMPK, Biomarkers), Regulatory Affairs, CMC, Biometrics, Pathology, and external CROs to design and execute toxicology programs supporting INDs, CTAs, BLAs, NDAs, lifecycle management activities, and responses to health authorities. The successful candidate combines deep scientific expertise with strategic judgment to identify and mitigate development risks while advancing innovative oncology therapeutics. 

Responsibilities

Scientific Leadership  

• Serve as the nonclinical safety lead for multiple oncology development programs from candidate selection through regulatory approval.  
• Develop integrated, phase-appropriate nonclinical safety strategies that support efficient clinical development while meeting global regulatory expectations.  
• Provide scientific leadership on target-, platform-, and modality-related safety risks and develop mitigation strategies.  
• Lead interpretation of complex toxicology findings and translate results into actionable recommendations for project teams and executive leadership.  
• Integrate toxicology, pharmacology, DMPK, pathology, biomarker, and clinical data into comprehensive benefit-risk assessments.   

Regulatory Strategy  

• Design nonclinical development plans supporting INDs, CTAs, NDAs, BLAs, and global regulatory interactions.  
• Author and review nonclinical sections of regulatory submissions including INDs, Investigator's Brochures, CTDs, briefing packages, orphan drug applications, pediatric plans, and responses to regulatory questions.  
• Represent Toxicology during FDA, EMA, PMDA, and other global health authority interactions.  
• Ensure nonclinical programs comply with ICH, FDA, EMA, OECD, and applicable global regulatory guidance.   

Study Oversight  

• Design, oversee, and interpret GLP and non-GLP toxicology studies conducted at external CROs.  
• Provide scientific oversight of study protocols, amendments, pathology peer review, data interpretation, and final reports.  
• Oversee study monitoring activities to ensure high-quality execution and data integrity.  
• Manage CRO performance, timelines, budgets, and scientific deliverables.   

Cross-Functional Leadership  

• Represent Toxicology on cross-functional project teams.  
• Partner with Clinical Pharmacology, Translational Sciences (DMPK, Biomarkers), Regulatory Affairs, CMC, Clinical Development, Biometrics, and Research to optimize development strategies.  
• Communicate complex scientific issues effectively to technical and executive audiences.  
• Mentor junior scientists and contribute to development of departmental capabilities and scientific standards.   

Innovation  

• Identify opportunities to incorporate emerging technologies including AI-enabled data analysis, predictive toxicology, in vitro models, large language models for scientific workflows, quantitative systems toxicology, and novel biomarkers.  
• Drive implementation of innovative approaches that improve decision-making, reduce development timelines, and align with regulatory expectations.  

Qualifications

• PhD, DVM, PharmD, MD, or equivalent in Toxicology, Pharmacology, Pathology, Biology, or related scientific discipline.  
• 12+ years of progressively responsible experience in biotechnology or pharmaceutical drug development, or equivalent experience.
• Extensive experience supporting oncology drug development programs through IND and late-stage clinical development.  
• Demonstrated success supporting multiple IND, CTA, NDA and/or BLA submissions.  
• Deep understanding of ICH, FDA, EMA and global regulatory expectations for nonclinical safety assessment. 
• Ability to travel approximately 10%, domestic and international.  

Knowledge and Skills

• Experience authoring relevant sections of global regulatory submissions and interacting with global health authorities in all stages of development and post-approval. 
• Excellent skills in assessment of the appropriate toxicology experiments to support clinical development at all stages of product development. Demonstrated experience supporting regulatory compliant nonclinical development plans, with excellent working knowledge of the regulatory process. 
• Experience in deployment of AI and other innovative technologies which improve decision making and align with regulatory partners. 
• Working knowledge of the most advanced exploratory and investigative toxicology methods to interrogate putative target and/or platform-related liabilities.  
• Excellent critical thinking skills, ability, and desire to oversee multiple projects simultaneously in a demanding environment. 
• Demonstrated experience in leading cross-functional teams in the development and execution of biomarker and diagnostics plans to support preclinical and clinical development. 
• Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly.  
• Experience with developing, leading, and executing translational strategies, such as the transition from discovery research into clinical development. 
• Ability to drive collaboration, achieve results, influence, and resolve conflicts across internal and external project teams.