Experienced Vice President with a demonstrated history of working in public health, acute care, academia and the biotechnology, medical devices and pharmaceuticals industries. Skilled in Epidemiology, Pharmacoepidemiology and Real-World Evidence. A highly collaborative and motivated professional widely respected by peers, colleagues and clients. A visionary leader, critical thinker and problem-solver.
Nineteen years of experience in pharmaceutical companies and clinical research organizations. Established the Epidemiology function at four companies with increasing levels of financial responsibility and global reach. Experienced principal investigator, scientific committee board member, published author, invited speaker and mentor.
Expert in Real-World Science with a deep understanding of real-world data applications across the product lifecycle to meet the needs of different stakeholders; in framing a public-health focused research questions; and, in real-world study design conceptualization, pharmacoepidemiologic methods, protocol and report development, and the interpretation and communication of study results.
Core competency in understanding and anticipating regulatory expectations. Experienced negotiating with and presenting to regulatory agencies. Passionate about patient safety and regulatory agency-mandated post approval safety studies. Comprehensive knowledge of global scientific and stakeholder requirements in support of efficacy evaluations in BLA and NDA submissions.