Focusing on key role of participants in clinical studies with opportunities for healthcare access and contributions to diversity in clinical trials
Current and former role as VP, Clinical Operations (SiteBridge Research, Takeda, Revance); VP Clinical Development (Meitheal/Xentria, AnaptysBio) and Head of Strategic Operations/Clinical Research Operations (Pfizer, Avexis, Astellas) leveraging early and late stage Drug Development and global clinical trials experience toward creating a high-performance teams and outsourcing plans for clinical trials
Experience in Global Development, Clinical Operations, Scientific Strategy and Clinical Affairs over the last 20+ years from bench to commercial; mergers, licensing and acquisitions and organizational evolution
Global experience including reports both within NA and outside US (including Canada, Eu, Jpn)
Former Astella’s Board member on AVOCA, Operations Committee member with Transcelerate, scientific development liaison for IFPMA/WHO Clinical Fellowship program.
Key driver — business case as part of Takeda strategy for Asia development operations in Singapore
Therapy areas of experience: Women’s Health, Musculo-skeletal Disorders, Oncology, Immunology/Inflammation, InfDiseases, Urology/Nephrology, CKD, Metabolic Diseases, CNS/Pain/Movement Disorders
Notable career achievements:
Contributions to development, regulatory submissions and/or approval of DaxibotulinumtoxinA, ZolgenSMA, Myrbetriq, Xtandi, Rozerem, Cresemba, ACTOS, Lipitor, Lyrica, Actonel; numerous INDs/ODAs including mabs for rare diseases, pivotal trials for dermatologic and respiratory diseases
Developing global strategy for Astellas’ Global Operating Model/Global Project Team, including implementation in US, EU and Jpn ; this model remains in place for some 2000+ colleagues in Astellas Medical/Development.
Globalizing Clinical Operations at Takeda, establishing ‘business units’ with Clinical Program Managers/Study Manager in alignment with key TAs for which Takeda was developing compounds and having high stds/global processes to run projects from Phase I – IV, including internal processes and those for overseeing outsourced study management activities.
Recognized leader and mentor Pfizer, Takeda and Astellas as a leader and mentor.