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 group in Shanghai to oversee non-clinical in vivo toxicology studies at contract research organizations. The role involves designing, monitoring, and reporting regulatory toxicology studies to support drug development and regulatory submissions across multiple 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
- Safety assessment experience from pharmaceutical or CRO industry
- Knowledge of regulatory toxicology study types across global health authorities and delivery routes
- Strong communication and influencing skills in multidisciplinary matrix teams
- Familiarity with regulatory principles, guidelines, and drug development toxicology discipline
- Experience across therapeutic areas and modalities (small molecules, antibody-drug conjugates, peptides, etc.) preferred
What you'll be doing
- Design, conduct, and report non-clinical in vivo toxicology studies in collaboration with CROs
- Serve as primary point of contact for CRO communication and conduct on-site study visits
- Work with Project Toxicologists to develop regulatory study strategies and assess safety risks
- Ensure high-quality toxicological data and documentation for clinical studies and marketing authorizations
- Apply in vivo toxicology expertise to challenge study designs and support cross-functional project teams
Privacy & handoff
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