Associate Director, Project Toxicologist – Immune Safety
Core
Design, deliver, and interpret innovative immune safety strategies to predict, assess, and mitigate target- and modality-related risks across the full value chain from target selection to clinical development.
Role type
Senior IC project toxicologist (immune safety)
Builds
Integrated safety packages, regulatory toxicology programs, and mechanistic risk assessments for immunology and immuno-oncology medicines.
Domain
Pharmaceutical R&D / Immunology Safety / Preclinical Toxicology
Required skills
Immune biology/toxicology expertise, B- and T-cell biology knowledge, in vitro and in vivo study design and interpretation, regulatory toxicology requirements, integrated risk assessment, study design refinement, translational biomarker strategies, scientific publication, mentoring
Preferred skills
Experience across multiple modalities (small molecules, biologics, complex biologics), DABT certification, leading external partnerships
Technologies
New Approach Methodologies (NAMs), omics, advanced imaging, computational tools
Responsibilities
Shape safety strategy across the value chain from target evaluation to IND-enabling studies and clinical development; Design and interpret integrated safety packages combining in vitro assays, NAMs, and omics data; Evaluate and mitigate target and immune-related risks including cytokine release and immunogenicity; Deliver regulatory toxicology programs including GLP studies and regulatory submissions; Influence decision-making by communicating risk positions to project teams and governance bodies; Advance the science by developing predictive methods and publishing in peer-reviewed journals; Mentor early-career toxicologists
Seniority
Senior, hands-on IC with leadership responsibilities