Study monitor - Regulatory toxicology
Study Monitor - Regulatory Toxicology
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. At AstraZeneca we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together.
With the aim of improving the quality of our medicines, AstraZeneca have established an innovative Drug Safety and Metabolism (DSM) Department. The DSM team sits within the AstraZeneca Innovative Medicine and Early Development (IMED) organisation and is committed to being an industry leader in supporting the discovery and non-clinical development of safe medicines that improve patients' lives. Within DSM, the Regulatory Safety group provides a broad portfolio of support starting with candidate nomination (dose-range finding toxicology) and following each project through to post-marketing. This is a global group with colleagues in Sweden, the USA and Cambridge, UK, our 3 strategic R&D sites.
Regulatory Safety, AstraZeneca R&D Cambridge UK is looking for a Study Monitor to support the outplacement of pre-clinical studies at Contract Research Organisations (CROs).
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. As a Study Monitor you will work closely with CROs and fellow AstraZeneca scientists to provide expert opinion 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.
Some of the responsibilities are outlined below:
- Understanding the practices, principles and concepts associated with planning and delivering fit for purpose non-clinical study programs.
- Working 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, efficient and excel at communicating. Additionally, be organised and systematic and a proactive 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.
- PhD or MSc in Pharmacology, Toxicology or a related Natural Science discipline. A BSc would also be acceptable for candidates with extensive 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.
- Results orientated with high scientific standards in combination with a delivery focus to support project execution.
Closing date: November 30th 2016
EQUAL OPPORTUNITIES STATEMENT
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual 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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.