Study Monitor, Safety Sciences China
AstraZeneca · Shanghai Jing'an
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Role summary
AstraZeneca seeks an experienced Study Monitor for its Safety Sciences China group to oversee non-clinical in vivo toxicology studies at contract research organizations. The role involves designing, conducting, and reporting regulatory toxicology studies to support drug discovery and clinical development across multiple therapeutic areas and modalities.
What they're looking for
- MSc or BSc in Pharmacology, Toxicology, or related Natural Science discipline
- Hands-on experience as GLP Study Director or Study Monitor for in vivo toxicology studies
- Background in both pharmaceutical and CRO industry settings
- Knowledge of regulatory toxicology study types across global health authorities and delivery routes
- Familiarity with multiple modalities: small molecules, radio-conjugates, antibody-drug conjugates, peptides
- Strong communication and influencing skills in multidisciplinary matrix environments
- Understanding of regulatory principles and guidelines in drug development
What you'll be doing
- Oversee design, execution, and reporting of toxicology and safety studies conducted at CROs
- Serve as primary contact for CRO communication and conduct on-site study visits
- Collaborate with AstraZeneca Project Toxicologists to design and deliver high-quality regulatory studies
- Apply expert judgment to challenge study designs using scientific principles and in vivo toxicology experience
- Lead regulatory toxicology study strategies to predict, assess, and mitigate safety risks
Privacy & handoff
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