Director, Toxicology

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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 in 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.

Washington State Pay Range

$216,197 - $270,100 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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