Location: Cambridgeshire, Gaithersburg, Maryland, Waltham, Massachusetts
Job Type: Full time
Level:Flexible, from Sr. Scientist, Associate Director, to Director
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
About AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness cente, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
About this position
You will work closely with clinical pharmacometricians, physicians and other scientists, and apply your expertise and leadership skills to contribute to the strategy of the clinical program and the design and interpretation of clinical studies. You will influence key decisions in early and late phases of clinical development. Accountable for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at the study level in compliance with Good Clinical Practice (GCP) regulations and internal/external mentorship, in support of projects (project team/governance). Jointly accountable with the clinical pharmacometrician for providing a scientific justification for the dose selection, for representing Clinical Pharmacology and Quantitative Pharmacology in cross-functional project teams, and for developing the clinical pharmacology strategy. Participation in and accountability for peer review of ongoing activities, reports and presentations. Contribute to regulatory documents and interactions (written and oral). Presentation of Clinical Pharmacology results within and outside of AstraZeneca and publish in peer reviewed journals. Contribute to internal initiatives to develop the clinical pharmacology field including its processes.
Education and experience requirements:
● PhD degree in a relevant field, or MS. or PharmD degree in a relevant field
● Industry experience or equivalent in pharmacokinetics and clinical pharmacology aspects of drug development
● Experience of writing and reviewing clinical trial protocols and reports and regulatory documents such as INDs, IBs, NDAs or BLAs
● Knowledge of pharmacokinetics, drug metabolism, and their clinical application and regulatory context
● Knowledge and experience in use of PK and PKPD modelling applied to life sciences
● Biological understanding of disease and drug action
● Translational science experience
● International scientific reputation gained from scientific publishing in the field of Clinical Pharmacology
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.