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 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 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 contribute to internal and external scientific reputation through internal and external collaborations, publications, and thought leadership. 

• Role 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.