Study Monitor, Safety Sciences China
Core
Lead regulatory and investigative toxicology study design, conduct, and reporting for non-clinical in vivo studies at CROs to enable clinical studies and marketing authorization.
Role type
Senior IC toxicology study monitor
Builds
High-quality toxicological data and documentation for drug candidates
Domain
Pharmaceutical R&D, non-clinical safety sciences, regulatory toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
in vivo toxicology expertise, GLP study design and execution, regulatory toxicology knowledge, CRO management, study design challenge, risk assessment, therapeutic area knowledge
Preferred skills
experience with small molecules, radio-conjugates, immune-cell engagers, antibody–drug conjugates, peptides, in vitro/in silico methods, organ-on-chip, omics
Technologies
GLP, CRO platforms, organ-on-chip, imaging, omics
Responsibilities
Design and report high quality regulatory studies to agreed deadlines, serve as accountable point of contact for CRO communications including on-site visits, contribute to study design concepts applying good scientific principles, assure ethical and efficient use of resources, communicate integrated risk assessments to governance bodies, maintain expertise in regulatory standards and emerging technologies
Seniority
Senior, hands-on IC