Senior Nonclinical Toxicology Project Lead (Biologics)

argenx SE; Oost-Vlaanderen; Hybrid; EUR 80.000 - 110.000; Vollzeit

Benefits dieser Stelle

Remote work option

On-site 2–3 days in Belgium

Incentives program

Zusammenfassung

argenx SE is seeking an experienced Project Toxicologist to lead nonclinical safety strategies for multiple modalities, including large molecules. Based in Belgium with on-site presence, you will shape safety packages, coordinate CROs, and ensure regulatory readiness while collaborating across PharmTox and clinical teams.

The role requires a PhD in toxicology, 5+ years in industry, and strong GLP and regulatory knowledge.

Qualifikationen

• PhD in toxicology with industry experience.
• 5+ years in a relevant position within industry.
• Strong understanding of nonclinical development and regulatory guidelines (ICH).
• Knowledge of nonclinical development of biotherapeutics is a plus.
• Excellent GLP understanding and experience managing outsourced activities.
• Ability to work in multidisciplinary teams and communicate effectively.

Aufgaben

• Provide strategic guidance on nonclinical safety screening and testing strategies for candidate compounds.
• Contribute scientific expertise to PharmTox discussions on programs and study designs across modalities.
• Coordinate outsourced activities with partner companies and CROs.
• Design nonclinical safety packages to enable clinical programs and secure stakeholder buy-in.
• Advise on interactions with Health Authorities and regulatory feedback.
• Oversee study execution with study monitors and ensure compliant conduct of studies.
• Collaborate with CMC, Bioanalytics, and Pharmacokinetics to integrate study outcomes.
• Present PharmTox responsibilities and deliverables to project teams and management.

Kenntnisse

Toxicology

GLP Knowledge

Outsourcing management

Cross-functional teamwork

Regulatory liaison

Ausbildung

PhD in Toxicology

Jobbeschreibung

argenx SE is seeking an experienced Project Toxicologist to lead nonclinical safety strategies for multiple modalities, including large molecules. Based in Belgium with on-site presence, you will shape safety packages, coordinate CROs, and ensure regulatory readiness while collaborating across PharmTox and clinical teams.

The role requires a PhD in toxicology, 5+ years in industry, and strong GLP and regulatory knowledge.