Job Details
Associate Director / Director of Clinical Pharmacology, Cardiovascular, Renal, and Metabolism (CVRM)
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
About this position
This is a an opportunity for an engaged and hardworking individual to join our growing Clinical Pharmacology and Quantitative Pharmacology (CPQP) team at AstraZeneca in Gaithersburg (Maryland, US) and contribute as a Associate Director/Director Clinical Pharmacologist in Cardio, Vascular, Renal, Metabolism, supporting large and small molecule projects across all phases of clinical development within the therapy area of Cardiovascular, Renal and Metabolism.
You will work closely with clinical pharmacometricians, physicians and other scientists, and apply your expertise and leadership skills to contribute to the strategy of the clinical program and the design and interpretation of clinical studies. You will influence key decisions in early and late phases of clinical development. Accountable for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at the study level in compliance with Good Clinical Practice (GCP) regulations and internal/external mentorship, in support of projects (project team/governance). Jointly accountable with the clinical pharmacometrician for providing a scientific justification for the dose selection, for representing Clinical Pharmacology and Quantitative Pharmacology in cross-functional project teams, and for developing the clinical pharmacology strategy. Participation in and accountability for peer review of ongoing activities, reports and presentations. Contribute to regulatory documents and interactions (written and oral). Presentation of Clinical Pharmacology results within and outside of AstraZeneca and publish in peer reviewed journals. Contribute to internal initiatives to develop the clinical pharmacology field including its processes.
Education and experience requirements:
* PhD degree or equivalent (MS. or PharmD) in a relevant field
* At least 3+ years industry experience or equivalent in pharmacokinetics and clinical pharmacology aspects of drug development (position level depends on overall years of proven experience)
* Experience of writing and reviewing clinical trial protocols and reports and regulatory documents such as INDs, IBs, NDAs or BLAs
* Knowledge of pharmacokinetics, drug metabolism, and their clinical application and regulatory context
* Background in, and a clear understanding of clinical pharmacology aspects of drug development, preferably in both a small and large molecule settings
* Knowledge and experience in use of PK and PKPD modelling applied to life sciences
* Biological understanding of disease and drug action
* Good oral and written communication skills
Desirable Criteria:
* Track record in creating and delivering on clinical pharmacology strategies of both small and large molecules
* Recognized clinical pharmacology expertise demonstrated by scientific publishing in the field of clinical pharmacology
* Early and late phase clinical development experience
Does this sound like your next challenge? Apply today!
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Date Posted
21-Mar-2024
Closing Date
20-Apr-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.