Director, Project Toxicologist Immune Oncology (IO) Safety Science

About This Role

This Director, Project Toxicologist role focuses on novel immunotherapeutics, including immune cell engagers, within the Immune Oncology (IO) Safety group. The successful candidate will partner with cross-functional teams across Oncology R&D, bridging discovery and regulatory toxicology and immunotoxicology. This position drives innovative safety strategies and accelerates drug development, informing candidate selection and guiding regulatory strategy.

Responsibilities

• Deliver globally acceptable toxicological packages to predict, assess, and mitigate target and modality-related safety risks
• Support data-driven decisions across discovery and development programs
• Develop and implement innovative solutions to combine regulatory toxicology with groundbreaking science and technologies
• Progress novel drug candidates to the clinic and through development to the market, in line with business needs
• Influence project strategy and decision-making
• Communicate clear positions on integrated risk assessments in various formats
• Inform internal decision-making governance bodies and interact with external health authorities
• Deliver quality non-clinical summaries and contribute to regulatory submissions for IO projects
• Maintain and expand expertise in regulatory standards, preclinical safety, and modality-specific safety science
• Stay ahead of industry trends
• Drive Oncology Safety science through internal and external collaborations, publications, and scientific leadership
• Provide experienced non-clinical evaluation of in-licensing and out-licensing opportunities
• Mentor and guide emerging toxicologists with respect to the regulatory environment
• Support career growth and development of emerging toxicologists
• Represent AstraZeneca interests, maintaining high ethical and scientific standards
• Support AstraZeneca’s Great Place to Work objectives

Requirements

• DABT or PhD in toxicology or immunology (or equivalent)
• Several years of experience in the pharmaceutical or biotechnology industry working as a non-clinical safety lead
• Supported immunology and/or oncology programs with planning, execution, interpretation, and communication of regulatory toxicology data
• Proven understanding of drug discovery and development
• Track record of delivering multiple toxicology programs supporting IND/CTA filings
• High level of knowledge and expertise in designing toxicology strategies
• Expertise in delivering in vitro/in vivo and risk assessment of immune/target related risks, driven by the pharmacology of IO therapeutics
• Ability to solve problems in a goal-focused fashion