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Location:
Royston, England, United Kingdom
Job reference: R-039213
Posted date: Dec. 03, 2018
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Position:                 Study Monitor

Location:                Cambridge, UK

Salary:                    Competitive, with excellent benefits

Regulatory Safety, AstraZeneca R&D Cambridge UK is looking for a Study Monitor to support the outplacement of pre-clinical toxicology studies at Contract Research Organisations (CROs)

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceutical and the supply of healthcare services. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re proud to have a unique workplace culture that inspires innovation and collaboration. At AstraZeneca, you will be able to express your diverse perspectives – and made to feel valued, energized and rewarded for your ideas and creativity.

We are investing in a state-of-the-art research centre in Cambridge, and we aim to bring together the finest talent in business and academia. You will join a dynamic and visionary team in a vibrant environment, where you can be part of making a difference for patients worldwide.

Our Function

Our Drug Safety and Metabolism (DSM) department has a strong track record of improving the quality of our medicines. We are committed to being an industry leader, supporting the discovery and non-clinical development of safe medicines that improve patients’ lives. Our Regulatory Safety Centre of Excellence provides cross-portfolio support from candidate nomination through to post marketing.

AstraZeneca are currently seeking a Toxicology Study Monitor, to be based at Cambridge, UK.

http://www.astrazeneca.co.uk/astrazeneca-in-uk/our-uk-sites/cambridge

The Role

We are looking for an experienced in vivo toxicologist, ideally 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 including all delivery routes and species. You will work closely with CROs and fellow AstraZeneca scientists to provide expert opinion in the design and interpretation of pre-clinical toxicity programmes ensuring the delivery of high quality toxicological documentation to enable clinical studies and marketing authorisation of drug candidates. You will work within a variety of research areas including oncology, respiratory and cardiovascular and metabolic disease and applicants with experience in reproductive toxicology are encouraged.

Responsibilities

The jobholder will have overall responsibility for the toxicology/safety studies run at CROs. You will be expected to work as an empowered and accountable member in study delivery teams, both for internal projects and in external collaborations.

A constructive, open and consultative attitude is required. You will:

  • Understand the practices, principles and concepts associated with planning and delivering fit for purpose non-clinical study programs.
  • Communicate regularly with CROs at all stages of studies, including on site study visits.
  • Work closely with AZ Project Toxicologists, internal experts and CRO Study Directors to design and report high quality regulatory studies to agreed deadlines.
  • Assure the most ethical and efficient use of resources (animals, time, money, people).
  • Be result oriented and efficient, you excel at communicating. Organised and systematic and a proactive team worker used to working in matrix environments.
  • Contribute with your own ideas and approaches and challenges the ways of working.
  • Embrace 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

  • PhD or MSc in Pharmacology, Toxicology or a related Natural Science discipline. A BSc would also be acceptable for candidates with significant relevant experience.
  • Safety assessment experience from preclinical research and development work within the pharmaceutical and/or CRO industry.
  • Hands on experience working as either a GLP Study Director and/or Study Monitor for in vivo pre-clinical studies.
  • Good command of pharmacological and/or toxicological principles and methods and the ability to familiarize 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.
  • Results orientated with high scientific standards in combination with a delivery focus to support project execution.
  • Flexible and adaptable to an evolving external and internal environment.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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Study Monitor
Scientific

AstraZeneca in the UK

Our 6,700-strong UK workforce is based across seven sites in the UK, including our new research facilities and global corporate headquarters in Cambridge. The Cambridge Biomedical Campus (CBC) is globally renowned as a leading centre of research, education and patient care. For AstraZeneca, the campus is the perfect environment in which to foster a vibrant culture of open innovation and collaboration.

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