AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Associate Director - Clinical Pharmacometrician, Early Clinical Development
Pioneer a new future to meet global healthcare challenges
We are committed to leading in sustainability. Backed by a belief in the connection between the health of our business, people and the planet. Be part of shaping a better future for all, supporting healthy communities by addressing the global societal and economic burden of disease. Help to limit our environmental impact by supporting our ambitious sustainability goals. From reducing our operational carbon footprint and waste generation, to driving efficient energy and water usage. And we do it all with ethics and transparency – doing the right thing in all our operations and interactions.
Who we are
Our workforce reflects the people we serve – diversity is embedded in everything we do. We’re at our best and most creative when drawing on our different views, experiences and strengths.
Why we love it
Thrive in an energising environment where challenging work goes hand in hand with development. With opportunities, recognition and forward-thinking minds, there’s no better place to unlock learning and build a long-term career.
What you will do
This is a scientific job with responsibility for translational modelling, population PK, PKPD, exposure-response, disease modelling, and simulations in all clinical development phases. With support from the Principal Pharmacometrician and the TA lead, the incumbent will be responsible for integrating and analysing internal (and external) data to support interpretation and decision making at the study level and with some support at the project level.
- Accountable for specialist data integration, analysis, interpretation, and reporting of M&S results at the study level
- Accountable for executing state-of-the-art M&S techniques with direct value for the project
- Use of M&S to influence study designs and go/no go decisions
- Development of (mechanistic) drug-disease models to support projects within a specific disease domain
- Contribute to regulatory documents and interactions (written)
- Presentation of M&S results in internal and external forum
- Contribute to internal initiatives to develop the pharmacometric subject area including its processes
- Participation in peer review of ongoing activities, reports and presentations
- Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance’s
Education, Qualifications, Skills and Experience
- PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required
- Relevant regulatory experience (written)
- Training and experience with PK and statistical software (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-Based Drug Development
- Demonstrated broad translational and clinical development expertise and experience exemplified by 3-6 Years 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
- Scientific publishing in the field on pharmacometrics
- Early or late phase clinical development experience/awareness
- Knowledge in pharmacology, drug targets and core disease areas
So, what’s next?
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!
Advertising opens on 27th August 2021 and we welcome with your application; CV and cover letter, no later than 27th September 2021
For more information please contact: email@example.com
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