Have over 25 years of clinical research and clinical operations experience in several therapeutic areas including oncology working within academic, sponsor, and contract research organizations. Have managed early to late phase clinical trials with direct reports and working with vendors for specific study design needs. Have assessed data collection/verification through final analyses ultimately used in progress, final study reports, and regulatory agency filings. Have worked with key opinion leaders and others in preparing clinical data for peer-reviewed publications and developed educational and other materials to focus on study site participation and recruitment strategy.. Privileged to have worked with teams to complete,
- Six (6) pharmaceutical trials which followed the IND path and were approved via an NDA.
- Three (3) IDE trials; ultimately approved via a PMA path.
- Three (3) trials which followed a 510(k) path with successful equivalency performance