Study Monitor, Safety Sciences China

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 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 expand   expertise   in regulatory standards, preclinical safety, and modality-specific safety science, staying ahead of industry trends.

- Innovate at the intersection of regulatory toxicology and   cutting-edge   science,   leveraging   in vitro, in silico, in vivo, and emerging technologies like organ-on-chip, imaging, and omics , and c ontribute to internal and external scientific reputation   through internal and external collaborations, publications, and thought leadership .

- R ole model demonstration of AZ Values.

Required   expertise   and experience

- MSc or BSc in Pharmacology,   Toxicology   or a related Natural Science discipline.

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

- Experienced   in vivo   toxicologist with   hands on   experience working as either a GLP Study Director and/or Study Monitor   for   in vivo   non-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,   species   and 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 rapidly   familiarise   with new therapeutic approaches.

- Familiarity with, and the application of,   appropriate regulatory   principles 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.

Date Posted
08-6月-2026

Closing Date

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 authorization and employment eligibility verification requirements.