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.Description:
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).Major Responsibilities
- 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
- Translational Scientists
- IPT/GPT leaders
- Credibility with academic partners, regulators and CROs
- 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 6 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
- 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)
- 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, in particular with regards to influencing skills
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. Next Steps - Apply today!
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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.
A little about us:
At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.