HeartWare International has announced the appointment of Katrin Leadley as chief medical officer effective 1 September, 2014. Leadley brings to HeartWare extensive strategic leadership, with more than 20 years of clinical and industry experience at life sciences firms, including Quintiles, Boston Scientific Corporation and JenaValve Technology in Munich, where she spent the last three years as chief medical officer leading the company’s clinical, regulatory, scientific and medical activities.
“Katrin has a wealth of clinical programme management experience, and we are confident she will be a great addition to our team,” says Doug Godshall, president and chief executive officer. “Her knowledge of cardiovascular device trials and her relationships with many of our international key opinion leaders will enable her to begin making contributions immediately. Katrin has proven experience in identifying new market opportunities, ensuring patient safety and executing clinical development plans and regulatory strategies to achieve product approvals and market introductions of new medical therapies. Katrin will help lead HeartWare through our next stage of clinical and commercial growth, as we advance our ongoing trials, initiate new studies and move toward obtaining regulatory approval of devices in our pipeline.”
During her time at JenaValve, Leadley oversaw the company’s global clinical programmes and worldwide regulatory strategy. She provided leadership and guidance as the company’s safety officer for all JenaValve products throughout the product lifecycle, and she offered medical guidance to the organisation’s Research & Development, marketing and physician training programmes. She was also responsible for the company’s scientific communications and for collaborating with key opinion leaders in the field.
Previously, Leadley spent eight years at Boston Scientific – based in San Jose, California and Munich – where she most recently served as global senior medical director, Clinical Sciences. During her time at Boston Scientific, Leadley oversaw the implementation of worldwide policies and processes for the medical and clinical sciences function of the cardiovascular platforms. She also provided medical oversight and participated in preparing regulatory submissions and approvals in the USA and Europe.
Leadley earned her medical degree at Ludwig-Maximilian University Medical School in Munich. She has authored numerous scientific and medical publications and presented at industry conferences and events around the world. She also was awarded a National Institute of Health Postdoctoral Fellowship by the School of Public Health at the University of California at Berkeley.
Leadley will succeed David Hathaway who has held the position of chief medical officer at HeartWare since 2008 and has decided to retire.