Toxicology Study Monitor, Genetic Toxicology
Location: Cambridgeshire, Gaithersburg, Maryland, Waltham, Massachusetts
Job Type: Full time
Make a more meaningful impact to patients’ lives around the globe
Here you’ll have the opportunity to make a meaningful 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. You’ll be part advancing our scientific knowledge and helping to shape the future of healthcare for the greatest and swiftest impact on disease to answer unmet medical needs by pioneering the next wave of science, focusing on outcomes, and shaping the patient ecosystem.
About AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
About AstraZeneca in Cambridge, UK:
Cambridge UK is one of the most exciting bioscience hotspots in the world. The Discovery Centre (DISC), located at the heart of the Cambridge Biomedical Campus, is designed to play a central role in our mission to deliver life-changing medicines to patients. As our largest research and development centre in the UK, it will have more than 2,000 people working across therapy areas and drug discovery and development once fully occupied. It is uniquely designed to strengthen collaboration, promote openness, and improve the sustainability of every aspect of our science and our business operations.
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.
To help deliver our expanding portfolio, AstraZeneca is currently seeking a Toxicology Study Monitor (Genetic Toxicology).
Regulatory Toxicology and Safety Pharmacology, AstraZeneca R&D is looking for a Toxicology Study Monitor to support the design, conduct and reporting of studies conducted at Contract Research Organisations (CROs)
You’ll 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.
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.
oUnderstand the practices, principles and concepts associated with planning and delivering a fit for purpose non-clinical study program.
oWork 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.
oBe the accountable point of contact for communication with CROs at all stages of studies, including on site study visits (some travel therefore required).
oContribute to and challenge study design concepts; applying good scientific principles utilising your experience of in vivo/vitro toxicology.
oAssure ethical and efficient use of resources (animals, time, money, people).
oBe result oriented and efficient.
oExcel at communication and project management as a proactive, organised and a systematic team worker used to working in matrix environments.
oEmbrace change and thrive in a dynamic working environment that is evolving to meet the needs of the business and the patient.
Required expertise and experience:
BSc or higher-level qualification in Pharmacology, Toxicology or a related Biological Science discipline.
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 vitrogenetic toxicology studiesas either a GLP Study Director and/or Study Monitor.
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 working knowledge of the science and testing requirements for regulatory genetic toxicology studies
Familiarity with, and the application of, appropriate regulatory principles and guidelines and the enthusiasm to work within and contribute to the discipline of Genetic 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.
Flexible, resilient, and adaptable to an evolving external and internal environment.
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.