Clinical Pharmacometrician

Gaithersburg, Maryland
Full time
Posted
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AstraZeneca
Science & biotechnology
10,001+ employees
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Job Description

Level: Flexible, from Sr. Scientist, Associate Director, to Director

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 one 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 guides 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 encourage 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 efficiency 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 growing collaboration between teams.

About this position

This is a scientific job with responsibility for pharmacometrics (PMx) activities including population PK, PKPD, exposure-response, disease modelling, and simulations in all clinical development phases. With support from Clinical Pharmacology Scientist and clinical team. The incumbent will be responsible for integrating and analysing internal and external data to support interpretation and decision making at both study level and project level.

The individual will drive the application of foundational and ground breaking pharmacometrics techniques, in combination with business domain knowledge, to develop and apply advanced modelling to generate business and scientific insights. They will likely coordinate the creation, maintenance and/or improvement of advanced pharmacometric models for ongoing and ad hoc review and analysis. The individual will provide coaching, task management and support to junior staff and promote best practice across multiple domains, and/or stakeholder groups.

Responsibilities:

  • Accountable for expert data integration, analysis, interpretation, and reporting of M&S results at the study 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

  • Development of drug-disease models to support projects within a specific disease domain

  • Contribute to regulatory documents and interactions (written)

  • Presentation of M&S results in internal and external forum

  • Contribute to internal initiatives to develop the pharmacometrics discipline including its processes

  • Participation in peer review of ongoing activities, reports and presentations

  • Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance's

Education and experience requirements:

● PhD degree, or MS degree in a relevant field, including but not limited to PKPD, engineering, mathematics, or statistics

● Academic or Industry experience in applying pharmacometrics tools, such as NONMEN, Monolix, R, etc.

● Knowledge of pharmacokinetics and drug metabolism are preferred.

● Biological understanding of disease and drug action