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Director, Clinical Pharmacology in Neuroscience & Vaccines and Immune Therapies

Plats Gaithersburg, Maryland, USA Jobb-id R-161839 Datum inlagd 03/17/2023
Job Description

Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you! 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 AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.  

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

Be encouraged and supported to think creatively in our dynamic environment. Here we are free from fear of failure, free to ask the right questions and make bold decisions.

Within the Clinical Pharmacology and Safety Sciences function, we have a state-of-the-art quantitative clinical pharmacology group with a diverse and uniquely skilled team of clinical pharmacometricians and clinical pharmacology scientists. Gaithersburg is a key research and development location for our Vaccines and Immune Therapies & Neuroscience area.

What you will do:

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.

Essential Criteria:

Education and experience requirements:

● PhD in a relevant field with 10+ years of relevant experience OR PharmD or MSci in a relevant field with 13+ years of relevant experience

● Industry experience or equivalent in pharmacokinetics and clinical pharmacology aspects of drug development

● Experience writing and reviewing clinical trial protocols and reports and regulatory documents such as INDs, IBs, NDAs or BLAs

● Knowledge of pharmacokinetics, its clinical application and regulatory context

● Knowledge and experience in use of PK and PKPD modelling applied to life sciences and biological understanding of disease and drug action

Why AstraZeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

So, what’s next?

Complete your application before the below closing date.

This role is open from 30/08/2022, we welcome with your application no later than 27/09/2022

Where can I find out more?

Follow AstraZeneca on LinkedIn

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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