Toxicologist Late Stage Clinical Development And Established Assets
argenx SE
Zwijnaarde, Belgium
Competitive salary pyckage; not specified; broad r...
Fully remote
Toxicology risk assessment expertise
Impurity and e&l risk management
Ich and ema/fda regulatory guidelines
The role involves leading product risk assessments for late-stage and established assets to support global regulatory and marketing expansion
Job Summary
The role involves leading product risk assessments for late-stage and established assets to support global regulatory and marketing expansion.
Candidates must be the single point of contact for impurity and extractables/leachables risk assessments across the entire portfolio in compliance with current guidelines.
The position offers a competitive salary package and flexible work arrangements including remote options from Belgium with part-time on-site presence in Ghent.
Matching Summary
The role involves leading product risk assessments for late-stage and established assets to support global regulatory and marketing expansion.
Salary
Competitive salary package; Not specified; Broad range of benefits
Skills & Requirements
Must-have
Toxicology risk assessment expertise
Impurity and E&L risk management
ICH and EMA/FDA regulatory guidelines
Health authority response experience
Cross-functional collaboration skills
Nice-to-have
Board certification (ERT or DABT)
In silico QSAR analysis interpretation
Servant leadership approach
Experience with medical device safety
Strong literature mining capabilities
Key Requirements
Ph.D. degree or equivalent experience
At least 5 years of industry toxicology experience