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Friday, November 6, 2020

Clinical Pharmacometrician

AstraZeneca - Waltham, MA - Clinical Pharmacometrician (Associate or Senior) Location: Waltham, MA (USA) Do you have experience in the clinical pharmacometric aspects of drug development, with model-informed drug development? AstraZeneca is seeking a proven Clinical Pharmacometrician that will support small and large molecule projects within Oncology. At AstraZeneca, we win through science, it's at the heart of our every success. That science is only possible when we all work together - we'll always make sure you're clear about how your role is connected to our wider mission to really show what science can do! As a Clinical Pharmacometrician you will work closely with physicians, clinical pharmacology scientists and statisticians, you'll be responsible for population PK, PKPD, exposure-response, disease modelling and simulation (M&S) efforts to support the design and interpretation of clinical studies, influence key decisions in the early and late clinical development and support regulatory submissions of our Oncology medicines. As the Clinical Pharmacometrician, your work includes integration and analysis of pharmacokinetic, biomarker and clinical endpoint data within and across studies, compounds and development stages. Input into trial designs using simulations and efficient modeling statistics is an important focus area for us. In collaboration with clinical pharmaology scientists, you'll represent CPQP on projects and contribute to the clinical pharmacology and pharmacometric strategy. You will communicate your findings to other scientists within AstraZeneca with the opportunity and expectation to present externally and publish in peer reviewed journals. This position is located in Waltham, MA The AstraZeneca R&D Waltham site is dedicated to cutting edge drug discovery, the facility is now a dynamic center where scientists from a variety of companies come together to share ideas and push the boundaries of science, with more buzz and more people than ever before! Th Waltham site is one of three AstraZeneca R&D sites to be transformed into a BioHub, along with Molndal, Sweden and Alderley Park, UK, where AstraZeneca researchers are working side-by-side with scientists from academic institutions to make strides in scientific discovery. AstraZeneca believes in what science can do and values the partnerships that contribute to the discoveries that ultimately help patients. Essential requirements Clinical Pharmacometrician PhD degree preferred or equivalent (M.Sc./Pharm.D.) with 0-3 years relevant experience required, MSc/PharmD required. Senior Clinical Pharmacometrician PhD degree preferred or equivalent (M.Sc./Pharm.D.) with 3-6 years relevant experience required, MSc/PharmD required. Training and experience with population PK and statistical software (e.g. NonMem, R, Stan, Winbugs, SAS, Monolix , Phoenix, WinNonlin) Demonstrated expertise in pharmacometrics, including PK, PKPD and/or statistics Strong quantitative skills (e.g. experience in population modelling, statistics, systems and translational pharmacology modelling). Expert knowledge of pharmacokinetics and Model-Informed Drug Development Demonstrated broad translational and clinical development expertise and experience exemplified by 0-3 yr (for associate) 3-6 Years (for senior) of drug development experience, with emphasis on Clinical Pharmacometrics Demonstrated ability to identify, develop and execute Pharmacometrics activities at a project level Good oral and written communication skills Good knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology You'll need real passion for your subject, along with a high level of integrity, plus demonstrated ability to work in multi-disciplinary global teams. Desirable requirements You will ideally have: Scientific expertise demonstrated by scientific publishing in the field of clinical pharmacometrics Early or late phase clinical development experience/awareness Knowledge in pharmacology, drug targets and Oncology More information Please contact: Karthick Vishwanathan at Benefits: AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It's our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees' varying needs, offers valuable choices, and is highly competitive. Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Come and join our journey - Apply today! Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram #pharmacometrics #oncology #pharmacometrician... - Permanent - Full-time

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