Toxicology Study Monitor (Genetic Toxicology)

Make a more meaningful impact to patients' lives around the globe



AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. Here you'll have the chance to create a significant difference to patients' lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines for the world's most complex diseases.



Our Function

Clinical Pharmacology & Safety Sciences (CPSS) is a multi-faceted department which underpins AstraZeneca's Biopharmaceutical and Oncology Portfolio from target selection through to Life-cycle management.

The Regulatory Toxicology and Safety Pharmacology group sits within CPSS and plays a central role in progressing a rich and diverse pipeline comprising many different modalities across our therapeutic areas of Oncology, Cardiovascular, Renal and Metabolic disease, Respiratory and Immunology, Neuroscience and Vaccines and Immune Therapies. We are committed to be an industry leader in supporting the nonclinical development of safe and effective medicines that improve patient's lives. This is a global group with colleagues in the UK, Sweden and the USA.



What you'll do


Regulatory Toxicology and Safety Pharmacology, AstraZeneca R&D is looking for a Toxicology Study Monitor (Genetic Toxicology) to support the design, conduct and reporting of studies conducted at Contract Research Organisations (CROs).



You will play a pivotal role in delivering our pipeline, working closely with many stakeholders to provide expert input into the planning, 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 responsibility for Genetic Toxicology Studies conducted 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 internal experts and the CRO Study Director to design and report high quality 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).
* Contribute to and challenge study design concepts; applying good scientific principles utilising your experience of in vivo/vitro toxicology.
* Assure ethical and efficient use of resources (animals, time, money, people).

Required expertise and experience



Essentials

* BSc or higher-level qualification in Pharmacology, Toxicology or a related Biological Science field.
* Safety assessment experience from non-clinical research and development work within the pharmaceutical/chemical and/or CRO industry.
* Experienced toxicologist with hands on experience supporting in vivo/in vitro genetic toxicology studies as either a GLP Study Director and/or Study Monitor.
* Demonstratable understanding of the science and testing requirements for regulatory genetic toxicology studies.
* Familiarity with, and the application of, appropriate regulatory principles and guidelines and the passion to work within and contribute to the field of Genetic Toxicology in a drug development setting.
* Excel at communication and project management as a proactive, organised and a detailed team worker used to working in matrix environments.
​

Desirables

* Strong candidates will be also familiar with the full range of non-clinical toxicology studies.
* Good command of pharmacological and/or toxicological principles and methods and the ability to rapidly familiarise with new therapeutic approaches.
* 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.
* Flexible, resilient, and adaptable to an evolving external and internal environment.
* Embrace change and thrive in a dynamic working environment that is evolving to meet the needs of the business and the patient.


Why AstraZeneca?


At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.



So, what's next! Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. We recommend that you send in your application as soon as possible, but no later than 19th march, 2023.

For more information, please contact hiring manager Shaun Maguire, Senior Director, Toxicology Study Monitor Group Lead, shaun.maguire@astrazeneca.com

Where can I find out more:
Our Gothenburg site: https://www.astrazeneca.com/our-company/our-locations/gothenburg.html
Life in Gothenburg: https://www.movetogothenburg.com/
AstraZeneca R&D: https://www.astrazeneca.com/r-d.html