Study Monitor, Safety Sciences China

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About the role

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 toxicology   expertise   to enable the discovery,   development   and registration of novel medicines.    We are   seeking   a highly motivated   Study Monitor ,   to join our   Safety Sciences China   group   t o help deliver our expanding portfolio,   working within a   global group   of   colleagues in the UK, Sweden,   USA   and India.   Ideally   we   are looking for an experienced   in vivo   toxicologist, 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 studies   required for   international Health Authority submissions ,   across therapy areas,   delivery routes, species and   a   range 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 Research   Organisations   (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 toxicity   programmes   ensuring the delivery of   high quality   toxicological data and documentation to enable clinical studies and marketing   authorisation   of 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 marketing   authorisation   of our medicines.   Responsibilities   You will have overall responsibility for the   toxicology/safety studies   run at CROs. You will be expected to work as an empowered and accountable member of the study team, supporting all aspects of study design,   execution   and 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 internal   experts   and the CRO Study Director to design and report high quality regulatory studies to agreed deadlines, communicating results to cross functional project teams.   • Be the accountable point of contact for communication with CROs at all stages of studies, including   on site   study visits (some travel therefore   required ).   • Work as   an expert   on in   vivo studies; contribute to and challenge study design   concepts   applying good scientific   principals   and   utilising   your   experience of   in vivo toxicology.   • Assure the most ethical and efficient use of resources (animals, time, money, people).   • Be result oriented and   efficient, and   excel at communicating and project management.  You are proactive,   organised   and a systematic team worker used to   working   in matrix environments.   • Embrace change and thrive in a dynamic working environment that is evolving to meet the needs of the business and the patient.   Job description   • Lead regulatory and investigative toxicology study design, developing strategies to predict, assess, and mitigate target- and modality-related safety risks.   • Apply your toxicology expertise to predict clinical safety risks and , as   core member of drug project teams,   support data-driven decisions across discovery and dev

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