Astrazeneca
Pharmaceuticals
StudyMonitor,SafetySciencesChina
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Study Monitor, Safety Sciences China at Astrazeneca. Skills: Toxicology, Study monitoring, Regulatory affairs. Support design, conduct and reporting of non-clinical in. Provide expert opinion in design and interpretation”
What You'll Achieve.
Deliver life-changing medicines; Enable discovery, development and registration; Deliver expanding portfolio; Deliver pipeline; Enable clinical studies; Enable marketing authorisation; Support project execution
Industry & Context.
Data-driven decisions
Some travel required
What They're Looking For.
Must Have
MSc or BSc in Pharmacology, Toxicology or related Natural Science, Safety assessment experience from non-clinical R&D, Experienced in vivo toxicologist, GLP Study Director and/or Study Monitor experience, Familiar with regulatory toxicology study types, Familiarity with regulatory principles and guidelines
Nice to Have
Experience across therapeutic areas and modalities, Hands on experience working as a GLP Study Director, Hands on experience working as a GLP Study Monitor
What You'll Do.
conduct and reporting of non-clinical in
Provide expert opinion in design and interpretation
Ensure delivery of high quality toxicological data
Enable clinical studies and marketing authorisation
Provide expert input into design
conduct and interpretation
Ensure delivery of high quality toxicological documentation
Oversee toxicology/safety studies run at CROs
Support all aspects of study design
Plan and deliver non-clinical study program
Design and report high quality regulatory studies
Communicate results to cross functional project teams
Serve as accountable point of contact for communication
Conduct on site study visits
Contribute to and challenge study design concepts
Apply good scientific principles
Utilize experience of in vivo toxicology
Assure ethical and efficient use of resources
Lead regulatory and investigative toxicology study design
Develop strategies to predict
Apply toxicology expertise to predict clinical safety risks
Support data-driven decisions across programs
Provide strategic toxicology input for in-licensing evaluations
Provide strategic toxicology input for external collaborations
Communicate integrated risk assessments to governance bodies
Contribute to regulatory submissions
Maintain and expand expertise in regulatory standards
Maintain and expand expertise in preclinical safety
Maintain and expand expertise in modality-specific safety science
Stay ahead of industry trends
Innovate at intersection of regulatory toxicology and science
Leverage emerging technologies like organ-on-chip
Leverage emerging technologies like imaging
Leverage emerging technologies like omics
Contribute to internal scientific reputation
Contribute to external scientific reputation
Engage in internal collaborations
Engage in external collaborations
Engage in publications
Engage in thought leadership
Demonstrate AZ Values
How You'll Work.
Team & Collaboration
Global group of colleagues; Fellow AstraZeneca scientists; Cross functional project teams; Multidisciplinary matrix teams; Drug project teams
Communication Scope
Communicating results; Communication
Process & Methodology
Project management
Full Job Description
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 to 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 **toxicolo
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