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Study Monitor Toxicology

4 months ago

Waltham, United States AstraZeneca Full time

Study Monitor Toxicology

Introduction to Role:
Join our dynamic team at AstraZeneca R&D's Regulatory Toxicology and Safety Pharmacology as a Toxicology Study Monitor. You will be instrumental in supporting the design, conduct, and reporting of non-clinical in vivo studies at Contract Research Organisations (CROs). This role is a key component in delivering critical support for our pipeline, working closely with our Project Toxicologists to provide expert input into the design, conduct, and interpretation of non-clinical toxicity studies. This ensures the delivery of high-quality toxicological documentation to enable clinical studies and marketing authorisation of our medicines. Ready to explore and innovate in our dynamic environment?

Accountabilities:
As a Study Monitor, you will have overall responsibility for the non-clinical toxicology/safety 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. Your role will involve understanding the practices, principles, and concepts associated with planning and delivering a fit-for-purpose non-clinical toxicology study program. You will work closely with AZ Project Toxicologists, other internal experts, and the CRO Study Director to design and report high-quality regulatory studies to agreed deadlines. As the accountable point of contact for communication with CROs at all stages of studies, you will also be required to make on-site study visits.

Essential Skills/Experience:

- Safety assessment experience from non-clinical research and development work within the pharmaceutical and/or CRO industry.
- Experienced in vivo toxicologist with hands-on experience working as either a GLP Study Director and/or Study Monitor for in vivo 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 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.

Desirable Skills/Experience:

- Familiarity with the full range of regulatory toxicology study types including all delivery routes, species, and a range of modalities
- Experience in working with advanced modalities (e.g., ADC, RNA products or cell therapies) would be an advantage.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.
That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca's Biopharmaceuticals R&D division, we are driven by our desire to understand and reveal new insights. We are free from fear of failure, free to ask the right questions, make bold decisions, and dig deep into the biology of complex disease. We are committed to making an impact on patients' lives, improving patient access to healthcare globally. Our values guide everything we do at AstraZeneca. They power our belief in What Science Can Do, a belief in its potential to redefine what's possible. We are always listening and learning from people who live with the diseases our medicines treat. It enables us to better understand their needs and, ultimately, diagnose and design the right treatments to impact patients' lives.