Safety Pharmacologist, Director
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals


Job Info


Safety Pharmacologist, Director

Introduction to Role:

Join our Safety & Mechanistic Pharmacology team at AstraZeneca as a Director, Safety and Mechanistic Pharmacology. We are currently seeking an experienced Safety Pharmacologist to help deliver our growing portfolio. Our team plays a central role in progressing a rich and diverse pipeline across all of our therapeutic areas. 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.

Accountabilities:

In this role, you will apply your extensive drug discovery expertise to support the progression of a broad portfolio of drug projects. You'll be responsible for authoring Safety Pharmacology sections of submission documents, engaging with and responding to Health Authority questions and contributing to the labelling of new products. You will also design and interpret safety pharmacology studies enabling first time in human submissions as well as investigative work at all stages. This will involve close collaboration with a wide range of experts in a highly matrixed environment across the development chain, for multiple project safety teams in parallel.

Essential Skills/Experience:

  • Extensive experience in pharmaceutical development, with a PhD (or equivalent experience) in pharmacology, toxicology, pathology or a related Natural Science field.
  • At least 5 years' experience working in an industry role with direct experience of Safety Pharmacology, with exposure to non-clinical safety assessment in projects both in discovery and development.
  • Track record of authoring nonclinical regulatory submissions (including Secondary and Safety Pharmacology sections) and involvement in health authority interactions.
  • Demonstrable expertise in the design and interpretation of in vitro and in vivo studies, translating scientific findings into applicable information in a drug development environment.
  • Familiarity with pharmacokinetic-pharmacodynamic and systems pharmacology approaches.
  • Validated ability to run a large portfolio of projects including prioritize activities in a matrix environment.
  • Understanding of the external factors that shape the scientific and regulatory landscapes relevant to Safety Pharmacology.
  • Proven strong scientific track record and problem-solving capabilities.

Desirable Skills/Experience:
  • In depth knowledge of cardiac function, ECG and imaging modalities.
  • Diplomat of Safety Pharmacology, DABT or ERT accreditation.
At AstraZeneca, 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 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. We are harnessing digital, data science & AI to help us achieve the next wave of breakthroughs.

Join us today! Be part of the team where you are empowered to follow the science. This is the place for curious minds. Dig deep into the biology of complex disease and uncover breakthroughs. Our belief powers us to push the boundaries. As we improve success rates, we keep moving forward. Celebrating both successes and failures along the way.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.



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