PostDoc Fellow: Optimizing Global and Regional Clinical Development Programs using Modeling and Simulation.
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. In the PostDoc Fellow position, you will be joining our our innovative academic-style Postdoc program based in Waltham, MA. Here you will be in a global pharmaceutical environment, contributing to live projects right from the start. What's more, you'll have the support of a leading academic advisor, who'll provide you with the guidance and knowledge you need to develop your career.
Completing a global clinical development program and receiving multiple local approvals is often a long process, which absorbs significant financial resources and usually delays market entry. Regulatory requirements are not always straightforward, resulting in a plethora of development pathways in different countries. Technical methods to integrate all available PK/PD data into population-based models for confirmatory demonstration of efficacy & safety have improved rapidly. Modelling and simulation (M&S) provide a framework for improving the efficiency of interrelated clinical development programs, through efficient integration of existing data and knowledge on a global scale. Thus, fundamental features such as prediction of ethnic differences, ethnic-based dose selection, safety characterization and comparative effectiveness can be characterized through M&S.
Integrating global and Japanese clinical development in Japan is particularly challenging. Although basic phase 1 studies are most often performed in Japanese or Japanese-ancestry subjects, the occurrence of phase 2 and 3 Japanese studies varies widely based on drug class, indication, and sponsor. The resulting Japanese dosage and instructions-for-use often deviate from global norms. Sponsors, including AstraZeneca, frequently duplicate large dose-ranging and efficacy studies, simply to demonstrate the lack of a specific effect in a Japanese population - often with large resources consumed, yet with limited public health benefits, while possibly delaying patient access to safe and effective treatments in Japan.
Areas for novel, integrative M&S research tailored to regional clinical development include:
Support for the choice of dose and dose regimen in an ethnic group, without new, separate dose-finding and efficacy studies Reduction of sample size and number of arms, in situations where regional dose-finding studies are required Characterization of ethnic population effects for both dose finding and efficacy through smaller bridging studies into global trials Improvement of population-based analysis of local sub-cohorts in global phase 2 and 3 studies, to reduce the need for separate local studies.
While developing methods of general application, the research program will use Japan as a focus and test-bed for the new methodologies.
This is a postdoctoral position in the area of statistical modelling. You will be based in the Department of Quantitative Clinical Pharmacology in AstraZeneca in Waltham, MA, and will be a member of the Interdisciplinary Program in Pharmacometrics which links pharmacometric experts across the Scientific Core Platforms.
As a Postdoctoral Scientist in Pharmacometrics and Statistics it's essential that you have:
* A PhD with a track record of productivity in the areas of statistics, pharmacometrics, mathematics, engineering or related field, as manifested in publications and presentations
* Good written and verbal communication skills as the position will require working with colleagues in cross-geographic locations
* Good team-worker in a multidisciplinary environment
* The ability to share knowledge and interpret findings
* A strong scientific track record, as evidenced by published or accepted papers in peer-reviewed journals, oral and/or poster presentations at scientific meetings
The following skills and qualifications are desirable:
* An understanding of pharmacology safety, pharmacokinetic, and pharmacodynamics
* Mathematical or statistical modelling, with experience in modelling biological data
* Hands-on familiarity with software platforms such as R, SAS, NONMEM, MATLAB, Phoenix or other software/scripting languages
* The capability and drive for performing applied pharmacometrics research, without the need for close supervision
As a Postdoctoral Scientist in Pharmacometrics and Statistics you will be:
* Involved in the development of statistical and pharmacological models in oncology, working as part of a modelling team and collecting clinical data in oncology, both from the public domain and in-house data
* Data assembling and manipulating using programs such as R and SAS
* Developing skills in both clinical pharmacology and pharmacometrics and its impact on the drug development process
* Actively engaging with all AstraZeneca and academic supervisors and collaborating with other scientists
* Communicating the results of modeling in presentations to key stakeholders and publishing scientific papers describing findings and any novel method/approaches
How to Apply:
This is a 2-year Fixed Term Contract opportunity, plus 1 year which will be merit based. The role will be based at Waltham, MA, US with a competitive salary on offer. To apply for this position, go to the AstraZeneca global career site ( https://job-search.astrazeneca.com ) and apply to job R-008136
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
This is a 2 year Fixed Term Contract opportunity, plus 1 year which will be merit based. The role will be based in Waltham, MA, US with a competitive salary on offer
If you share our passion for scientific excellence, find out more at careers.astrazeneca.com
A little about us:
At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.