Senior Clinical Pharmacometrician, Early Clinical Development AstraZeneca is dedicated to discovering, developing, and delivering innovative, meaningful medicines and other healthcare solutions that help enrich the life of patients, as well as their families and communities. At AstraZeneca Oncology, our vision is redefining cancer, redefining our solutions to cancer and restoring patients' lives.
In this scientific position you with responsibility for translational modelling, population PK, PKPD, exposure-response, disease modelling, and simulations in all clinical development phases. You will apply state-of-the-art modelling and simulation (M&S) approaches to influence designs and internal/external decision making at the project level. You will also support global initiatives to develop the pharmacometric discipline and at times mentor junior staff. In this role, you will work closely with project colleagues to ensure appropriate implementation of model based drug development (MBDD).
Accountable for expert data integration, analysis, interpretation, and reporting of M&S results at the project 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
Scientific and strategic input into pre-clinical, clinical, and post-approval development plans
Development of (mechanistic) drug-disease models to support projects within a specific disease domain
Contribute to regulatory documents and interactions (oral/written)
Presentation of M&S results in internal and external forum
Support evaluation of candidates for in-licensing
Contribute to internal initiatives to develop the pharmacometric discipline including its processes
Participation in and accountability for peer review of ongoing activities, reports and presentations
Supervision of modelling work performed by external contractors and more junior pharmacometricians, graduate students and post-doc
Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance's
Clinical Pharmacology Scientists
DMPK M&S experts
Credibility with academic partners, regulators and CROs
PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required
Significant demonstrated expertise within the field of M&S, including PK, PKPD and statistics
Expert knowledge of pharmacokinetics and Model-Based Drug Development (T)
Demonstrated broad translational and clinical development expertise and experience exemplified by at least 10 years of drug development experience, with emphasis on Pharmacometrics.
Excellent oral and written communication skills
Demonstrated ability to identify, develop and execute strategic M&S activities at the project level
A demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to pharmacometrics
Relevant disease domain knowledge
Relevant regulatory experience (written/oral)
Skilled in relevant software's and tools within the field of M&S
Relevant regulatory experience (written)
Training and experience with PK and statistical software (NonMem, R, Stan, Winbugs ,SAS, Monolix , Phoenix, WinNonlin)
International scientific reputation gained from scientific publishing in the field on pharmacometrics
Experience in several organisations
Expert knowledge in pharmacology, drug targets and core disease areas
Good leadership capabilities, with regards to influencing skills
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.