Kristen Bibeau

WORK HISTORY

EDUCATION

SKILLS

ABOUT KRISTEN BIBEAU

Experienced pharmacoepidemiologist across the development lifecycle, with primary focus on RWE Generation and pharmacoepidemiologic designs. As Global Executive Director of Development RWE at Shionogi, I lead initiatives that transform real-world data into actionable insights for our development programs to improve patient outcomes and inform strategic decision-making. With a strong foundation in evidence-based innovation and a passion for patient-centered research, I specialize in leveraging advanced analytics, data science, and global partnerships to drive value across the drug development lifecycle. My mission is to bridge science and strategy—ensuring that real-world evidence shapes the future of healthcare.My experience extends broadly from indication prioritization pre-clinical to COA and endpoint selection and strategy, and into post-authorisation safety studies (PASS), including authorship of regulatory documents. In addition to formal epidemiology training, I have deep experience in psychometric applications to support COA selection and validation. I\'ve led numerous observational epidemiology and outcomes studies utilizing prospective and retrospective designs, large administrative datasets, and de novo data collection. Throughout my career, I have worked across nearly all therapeutic areas, most recently in oncology, immunology, dermatology and rare diseases. I hold over 20 years of experience working in the biopharmaceutical industry, as well as regulatory experience via positions held at the US FDA. I thrive on quick thinking, out-of-the-box scenarios, mentoring enthusiastic epidemiologists, and focused research that keeps our patients at the heart of everything we do!