Study Monitoring Scientist, Safety Pharmacology

Study Monitoring Scientist Safety Pharmacology

Study Monitoring Scientist Safety Pharmacology

Location: UK, Cambridge

Competitive salary and benefits

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

At AstraZeneca you’ll have the chance to create 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 sophisticated diseases. Answer unmet medical needs by ground-breaking the next wave of science, focusing on outcomes and crafting the patient ecosystem.

Always advancing our scientific knowledge and helping to shape the future of healthcare for the greatest and swiftest impact on disease.

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 team 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.

We work collaboratively to deliver safety science from early discovery through clinical development, with emphasis on the science and studies required to enable the clinical development of new medicines. To help deliver our growing portfolio, AstraZeneca are currently seeking a Study Monitor, focusing on Safety Pharmacology.

The Role

Regulatory Toxicology and Safety Pharmacology, AstraZeneca R&D is looking for a Study Monitor, primarily supporting our Safety & Mechanistic Pharmacology team, to support the design, conduct and reporting of non-clinical in vivo safety pharmacology studies at Contract Research Organisations (CROs) worldwide.

You’ll play a pivotal role in delivering our pipeline, working closely with many collaborators, including our Project Toxicologists and Safety Pharmacology Specialists, to provide expert input into the design, conduct and interpretation of non-clinical Safety Pharmacology studies, ensuring the delivery of high quality documentation to enable clinical studies and marketing authorisation of our medicines.

Responsibilities

You will have overall responsibility for safety pharmacology studies run at CROs. You will be encouraged to work as an empowered and accountable member of the study team, supporting all aspects of study design, execution and reporting.

  • Understand the practices, principles and concepts associated with planning and delivering a fit for purpose non-clinical study program.

  • Work closely with our Safety Pharmacology Specialists, 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).

  • Be seen 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 and safety pharmacology.

  • 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, very well organised and a team worker used to working in matrix environments.

  • Operate across international boundaries within CPSS and across R&D functions in AstraZeneca to lead and run projects and partners

  • Adopt change and thrive in a dynamic, fast paced working environment that is evolving to meet the needs of the business and the patient.

Requirements

  • A university degree or evidence of proven experience in toxicology, pharmacology or equivalent life-science subject is required.

  • Experience working on non-clinical regulatory studies ideally as a Study Director or a study monitor, with an understanding of key guidelines required for drug development.

  • Experience or solid understanding of Safety Pharmacology and the relevant regulatory guidelines and assay requirements for pharmaceuticals, including Good Laboratory Practice.

  • Experience in providing design and interpretation of Safety Pharmacology data.

  • You should be highly motivated, innovative, diligent, creative, well organized, with particular attention to detail, and able to work independently when designing and implementing experiments and will be expected to lead and prioritize several different projects and tasks in line with the objectives of the team.

  • Willingness to challenge conventional thinking and implement creative ideas balanced with a high regard and understanding for the regulatory framework in which AstraZeneca operates is expected.

  • A committed person with strong inter-personal skills that contributes to our team culture in which trust, cooperative support, diversity and inclusion enable engaged and motivated colleagues to deliver and develop.

So, what’s next?

Complete your application before the below closing date.

This role is open from 2nd February 2022 until 17th February 2022

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Email Me Jobs Like These
Showing 1–0 of 0 jobs

Privacy Policy / BBSTEM Limited | Registered in England and Wales | Company No: 11127036