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Title

Senior Director, Clinical Pharmacology and Quantitative Pharmacology 

EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
 
About the Organization
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com .  
Description

What are the objectives/goals of the position?

It is well recognized in the literature that 4Beta hydroxy cholesterol is a marker for CYP3A induction. There have been several publications that have shown the potential for this biomarker for induction. At AZ, based on the publication by Jones et al, DMD 2016 “Managing the Risk of CYP3A Induction in Drug Development: A Strategic Approach”, every multiple ascending dose study have evaluated 4BHC at baseline and at steady state over the last 4 yrs. In this work, the summer intern will evaluate all available data to understand and answer the following questions.

  1. Does baseline 4BHC levels change in case of cancer patients compared to healthy volunteer studies that is currently available in the literature. Compare the variability using statistical approaches.
  2. Does the change in 4BHC correlate with the change in midazolam or the AZ compounds in vitro characteristics? Evaluate the translatability of the marker from in vitro data to the clinical outcomes across AZ portfolio of compounds that has been evaluated.
  3. In summary, conclude the potential validity and criteria that can be used to classify the marker. Furthermore, evaluate the value of continued evaluation of 4BHC as a biomarker in SAD/MAD studies.

What are the primary duties of this position? 

Statistical analysis of the data using appropriate statistical models; understanding the biomarker, its impact on metabolism

 
Position Requirements

Position Requirements: 

  1. Statistics,

  2. R,

  3. excel,

  4. powerpoint,

  5. metabolism and pharmacokinetics

 
Full-Time/Part-Time Seasonal  
Location Waltham, MA  

This position is currently not accepting applications.

To search for an open position, please go to http://AstraZenecaPharmaceuticalsInc.appone.com



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