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Senior Scientist – Clinical Pharmacometrics
| Company | AstraZeneca |
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| Location | Gaithersburg, MD, USA |
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| Salary | $116670 – $175005 |
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| Type | Full-Time |
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| Degrees | PhD, MD |
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| Experience Level | Senior |
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Requirements
- PhD degree or equivalent (Pharm.D.) with 0-5 years of pharmacometrics experience
- 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 (MIDD)
- Demonstrated broad translational and clinical development expertise and experience exemplified of drug development experience, with emphasis on Clinical Pharmacometrics
- Demonstrated ability to identify, develop and execute Pharmacometrics activities at a project level
- Excellent oral and written communication skills
- Good knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology
- Relevant regulatory experience (written)
- Training and experience with PK and statistical software (NonMem, R, Stan, Winbugs, SAS, Monolix, Phoenix, WinNonlin)
Responsibilities
- Develop modeling & simulation (M&S) strategy to support dose selection at all stages
- Analyze M&S data, interpret results, and convey clear messages to project teams
- Deliver key messages to LM, TA heads, and function heads alongside CPL
- Contribute to key regulatory meetings, such as EOP2
- Inform LM, TA head, and function head with key messages
- Use M&S to influence study designs and go/no-go decisions
- Contribute to regulatory documents and interactions (oral/written)
- Support evaluation of candidates for in-licensing
- Contribute to internal initiatives to develop the pharmacometric discipline including its processes
- Supervise modelling work performed by external contractors
- Ensure compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance
- Represent AZ by publishing research findings, presenting at conferences, and organizing symposia
Preferred Qualifications
- Prior industry experience is preferred
- Scientific publishing in the field on pharmacometrics
- Early or late phase clinical development experience/awareness
- Knowledge in pharmacology, drug targets and core disease areas
