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 experienced in 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 for international 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 the toxicology/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.

• Be the accountable point of contact for communication with CROs at all stages of studies, includingon sitestudy visits (some travel thereforerequired).

• Work asan experton invivo studies; contribute to and challenge study designconceptsapplying good scientificprincipalsandutilisingyourexperience ofin vivo toxicology.

• Assure the most ethical and efficient use of resources (animals, time, money, people).

• Be result oriented andefficient, andexcel at communicating and project management.  You are proactive,organisedand a systematic team worker used toworkingin matrix environments.

• Embrace change and thrive in a dynamic working environment that is evolving to meet the needs of the business and the patient.

• 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, ascore member of drug project teams,support data-driven decisions across discovery and development programs.

• Provide strategic toxicology input for in-licensing evaluations and external collaborations.

• Communicate integrated risk assessments to governance bodies and contribute to regulatory submissions.

• 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

• Role model demonstration of AZ Values.

Requiredexpertiseand experience

• MSc or BSc in Pharmacology,Toxicologyor a related Natural Science discipline. 

• Safety assessment experience from non-clinical research and development work within the pharmaceutical and/or CRO industry.

• Experiencedin vivotoxicologist withhands onexperience working as either a GLP Study Director and/or Study Monitorforin vivonon-clinical toxicology studies.

• Strong candidates will be familiar with the full range of regulatory toxicology study types (across global health authorities) including all delivery routes,speciesand a range of modalities.

• Experience across therapeutic areas and modalities (small molecules, radio-conjugates, immune-cell engagers, antibody–drug conjugates, peptides) is desirable.

• Good command of pharmacological and/or toxicological principles and methods and the ability to rapidlyfamiliarisewith new therapeutic approaches.

• Familiarity with, and the application of,appropriate regulatoryprinciples and guidelines and the enthusiasm to work within and contribute to the discipline of Toxicology in a drug development setting.

• A dedicated team player with excellent communication and influencing skills with experience working in multidisciplinary matrix teams.

• Results orientated with high scientific standards in combination with a delivery focus to support project execution.