Jonathan Rowe, PhD, MS, MA

Senior Consultant
AQC
 

 

For 30 years, Jonathan has held roles across pharmaceutical sponsors and consulting/advisory services. His breadth of experiences and accountabilities crosses Good Clinical Practice, Quality, clinical development, medical affairs, intellectual property strategy, portfolio management, business development and pharmaceutical sciences.

From 2020-2026 Jonathan was the founder and lead for ZS’s GCP Quality, Operations and Risk Management practice, working with dozens of sponsors to drive innovative approaches to clinical development, RBQM and quality. His organization was independently recognized by IDC marketplace as a leader in their field. From 2014 through the end of 2019, Jonathan was the Global Head of Clinical Development Quality Performance and Risk Management at Pfizer where his responsibilities included developing, monitoring, modeling, and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance, and ensuring clinical trial quality risk management was built into all trials. His responsibilities included the development portfolio, GCP processes, vendors and sites. From 1998-2002 Jonathan was the Clinical Director for Lipitor responsible for phase IIIB and IV trials as well as medical affairs functions.  From 2002-2007 he held leadership roles in strategic groups with accountability for Pfizer’s intellectual property portfolio and pharmaceutical sciences process oversight. In 2009 Jonathan joined Amarin as the Head of Intellectual Property and Portfolio Strategy  and was a key member of the team that raised $70M USD in 2009 to fund Amarin’s Phase III cardiovascular program, leading to the approval of Vascepa.

Jonathan is an author of many publications including Transcelerate’s key papers entitled “Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development” and a contributing author on, “Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development.” Jonathan has multiple additional peer reviewed publications and is an inventor on eight patents.

Jonathan earned his PhD and MS at the Albert Einstein College of Medicine and his M.A. from Binghamton University.