Associate Director, Safety Pharmacology Study

3 weeks ago

Cambridge, United Kingdom AstraZeneca Full time

**Locations : UK (Cambridge), US (Boston/Gaithersburg), Sweden (Gothenburg)**

**Bring out the best in each other, and yourself, by working together as one**

In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace.

**Who we are**:
Encouraged to speak up and break new ground, we are entrepreneurs and innovators It’s our bold spirit that drives us to spot opportunities, make quick decisions and take smart risks.

**How we do it**:
Committed to living our values - they guide our behaviours, actions and decisions, every day.

It drives us to work together as one global team to achieve our goals. A supportive place where all are encouraged and achievement is recognised. Strengthening our knowledge through constructive feedback and coaching, as well as collaborating with the best.

**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 expanding portfolio, AstraZeneca are currently seeking a **Study Monitor, **focusing on Safety Pharmacology (with experience in cardiovascular, respiratory and CNS studies).

**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. You will also be involved in the design, inclusion and analysis of Safety Pharmacology endpoints in pivotal Toxicology studies (for example ECG).

**Responsibilities**:
You will have overall responsibility for safety pharmacology studies run 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.
- 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 timelines, 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).
- 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, extremely 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 manage projects and partners
- Embrace change and thrive in a dynamic, fast paced working environment that is evolving to meet the needs of the business and the patient.

**Requirements**:

- 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 working knowledge 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.
- Experience/knowledge of including Safety Pharmacology endpoints on pivotal toxicology studies (such a Jacketed External Telemetry (JET) ECG & Respiratory Inductive Plethysmography (RIP) is advantageous.
- You should be highly motivated, innova

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