Associate Director, Clinical Pharmacology and Pharmacometrics
Associate Director Clinical Pharmacology and Pharmacometrics (Clinical Pharmacology)
Introduction to Role:
Are you ready to make a meaningful impact on patients' lives? We are looking for an Associate Director Clinical Pharmacology to join our dedicated Research & Development team in the Biopharmaceuticals R&D department. This scientific role works closely with Clinical Pharmacometricians and the clinical team to create clinical pharmacology development programs, providing a clear strategy towards the right dose for patients. The position is based at the Gaithersburg, MD, USA AstraZeneca site in the Lifecycle and Post-Market and Lifecycle Management Group.
Accountabilities:
As an Associate Director, you will be accountable for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at the study level to support project decisions. You will work jointly with the pharmacometrician to provide a scientific justification for dose selection. Your responsibilities will also include contributing to regulatory documents and interactions, presenting Clin Pharm results to internal and external forums, and contributing to internal initiatives to develop the clinical pharmacology discipline.
Requirements:
- Expert knowledge of pharmacokinetics and Model-Informed Drug Development (MIDD)
- Good knowledge in pharmacology, drug targets and core disease areas
- Demonstrated broad translational development expertise and experience exemplified by at least 3 years drug development experience, with emphasis on Clinical Pharmacology
- Demonstrated ability to identify, develop and execute clinical pharmacology 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
- PhD degree with relevant experience required
- Relevant regulatory experience (written)
- Training and experience with PK software (Phoenix, WinNonlin)
Desirable Skills/Experience:
- International scientific reputation gained from scientific publishing in the field of DMPK/Clinical Pharmacology
- Experience in early and late stage drug development
- Experience with relevant software and tools within the field of MIDD (e.g. SIMCYP, R, NONMEM)
When we put unexpected teams the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
At AstraZeneca, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before.
Ready to make a difference? Apply now and join us in our mission to deliver life-changing medicines!
Introduction to Role:
Are you ready to make a meaningful impact on patients' lives? We are looking for an Associate Director Clinical Pharmacology to join our dedicated Research & Development team in the Biopharmaceuticals R&D department. This scientific role works closely with Clinical Pharmacometricians and the clinical team to create clinical pharmacology development programs, providing a clear strategy towards the right dose for patients. The position is based at the Gaithersburg, MD, USA AstraZeneca site in the Lifecycle and Post-Market and Lifecycle Management Group.
Accountabilities:
As an Associate Director, you will be accountable for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at the study level to support project decisions. You will work jointly with the pharmacometrician to provide a scientific justification for dose selection. Your responsibilities will also include contributing to regulatory documents and interactions, presenting Clin Pharm results to internal and external forums, and contributing to internal initiatives to develop the clinical pharmacology discipline.
Requirements:
- Expert knowledge of pharmacokinetics and Model-Informed Drug Development (MIDD)
- Good knowledge in pharmacology, drug targets and core disease areas
- Demonstrated broad translational development expertise and experience exemplified by at least 3 years drug development experience, with emphasis on Clinical Pharmacology
- Demonstrated ability to identify, develop and execute clinical pharmacology 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
- PhD degree with relevant experience required
- Relevant regulatory experience (written)
- Training and experience with PK software (Phoenix, WinNonlin)
Desirable Skills/Experience:
- International scientific reputation gained from scientific publishing in the field of DMPK/Clinical Pharmacology
- Experience in early and late stage drug development
- Experience with relevant software and tools within the field of MIDD (e.g. SIMCYP, R, NONMEM)
When we put unexpected teams the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
At AstraZeneca, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before.
Ready to make a difference? Apply now and join us in our mission to deliver life-changing medicines!
Start date: ASAP
Salary: Negotiable
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