Location: Gothenburg, Sweden
Function: Clinical Pharmacology & Safety Sciences – Immunology Safety
At AstraZeneca, our bold ambition is to achieve disease modification, clinical remission, and cure for people living with immune mediated diseases. We are expanding our diverse Immunology pipeline and building leadership across multiple indications.
To fuel this ambition, we are seeking a motivated, scientifically curious and collaborative Project Toxicologist in Immune Safety to join our team in Gothenburg . This is a unique opportunity to shape immune safety strategies across the full value chain — from early target selection and candidate optimization, through IND-enabling studies, and on into clinical development and regulatory submission. Join our Immunology Safety team and help deliver transformative, safe medicines to patients worldwide.
What you will do
As a core member of multi-disciplinary immunology drug project teams, you will design, deliver, and interpret innovative safety strategies to predict, assess and mitigate target- and modality-related risks. Your key accountabilities will include:
Shape safety strategy across the value chain: Provide immune safety leadership from target evaluation and modality selection, through candidate optimization and selection, IND-enabling in vivo toxicology packages, and clinical development milestones.
Design and interpret integrated safety packages: Combine data from in vitro immune assays, New Approach Methodologies (NAMs), cellular immunology, in vivo models, omics, advanced imaging, translational biomarkers and computational tools to build mechanistic risk assessments that guide project decisions. Apply a scientifically robust, fit-for-purpose and 3R-aligned approach, integrating NAMs and other non-animal methods in line with modern regulatory initiatives aimed at reducing reliance on animal testing.
Evaluate and mitigate target and immune-related risks: Assess on- and off-target liabilities including cytokine release, immunomodulation, immunogenicity considerations, and immune cell subset perturbations, and propose mitigation strategies via study design refinement, monitoring plans and translational biomarkers.
Deliver regulatory toxicology programs: Design, execute, interpret and report GLP toxicology studies; author high-quality nonclinical summaries and contribute to IND, CTA, BLA/NDA and other regulatory submissions, and represent AstraZeneca nonclinical safety in interactions with health authorities.
Influence decision-making: Communicate clear, integrated risk positions to project teams, cross-functional R&D partners, and internal governance bodies.
Advance the science: Contribute to the development of cutting-edge predictive immune safety methods; publish in peer-reviewed journals and present at international scientific meetings, get involved in your local toxicology community.
Evaluate external opportunities: Provide expert nonclinical assessment of in-licensing and out-licensing opportunities.
Develop others: Mentor and guide early-career toxicologists, supporting their scientific and career growth.
Essential qualifications
PhD in immunology, toxicology, pharmacology or a related discipline (or equivalent experience), with familiarity with immune biology/toxicology, including B- and T-cell biology .
Demonstrated industry experience in the pharmaceutical or biotech sector as a nonclinical safety scientist supporting immunology and/or immuno-oncology programs, spanning both discovery and development activities.
Proven track record of contributing to target evaluation, candidate optimization, and delivering toxicology programs to IND and through clinical development.
Hands-on expertise designing and interpreting in vitro and in vivo studies (including functional immune assays, cytokine release, immunophenotyping, translational biomarker strategies), with the ability to interpret data in a mechanism-driven framework.
Strong knowledge of regulatory toxicology…