At AstraZeneca, we push the boundaries of science to deliver life-changing medicines. Our global Safety Sciences organization delivers innovative non-clinical safety science and toxicologyexpertiseto enable the discovery,developmentand registration of novel medicines.
We areseekinga highly motivatedStudy Monitor,to join ourSafety Sciences Chinagroupto help deliver our expanding portfolio,working within aglobal groupofcolleagues in the UK, Sweden,USAand India.Ideallyweare looking for an experiencedin vivotoxicologist, with a background in both the CRO and pharmaceutical industries as a Study Director/Study Monitor. Strong candidates will be familiar with the full range of regulatory toxicology studiesrequired forinternational Health Authority submissions,across therapy areas,delivery routes, species andarange of modalities(small molecules, radio-conjugates, immune-cell engagers, antibody–drug conjugates, peptides, etc).
The Role
Regulatory Toxicology and Safety Pharmacology, AstraZeneca R&D is looking for a Toxicology Study Monitor to support the design, conduct and reporting of non-clinical in vivo studies at Contract ResearchOrganisations(CROs).As a Study Monitor you would work closely with CROs and fellow AstraZeneca scientists to provide expert opinion in the design and interpretation of non-clinical toxicityprogrammesensuring the delivery ofhigh qualitytoxicological data and documentation to enable clinical studies and marketingauthorisationof drug candidates.You’ll play a pivotal role in delivering our pipeline, working closely with many stakeholders, including our Project Toxicologists, to provide expert input into the design, conduct and interpretation of non-clinical toxicity studies, ensuring the delivery of high quality toxicological documentation to enable clinical studies and marketingauthorisationof our medicines.
Responsibilities
You will have overall responsibility for thetoxicology/safety studiesrun at CROs. You will be expected to work as an empowered and accountable member of the study team, supporting all aspects of study design,executionand reporting.
You should:
Understand the practices, principles and concepts associated with planning and delivering a fit for purpose non-clinical study program.
Work closely with AZ Project Toxicologists, other internalexpertsand the CRO Study Director to design and report high quality regulatory studies to agreed deadlines, communicating results to cross functional project teams.
Lead regulatory and investigative toxicology study design, developing strategies to predict, assess, and mitigate target- and modality-related safety risks.
Maintain and expandexpertisein regulatory standards, preclinical safety, and modality-specific safety science, staying ahead of industry trends.
Innovate at the intersection of regulatory toxicology andcutting-edgescience,leveragingin vitro, in silico, in vivo, and emerging technologies like organ-on-chip, imaging, and omics, and contribute to internal and external scientific reputationthrough internal and external collaborations, publications, and thought leadership.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
