- 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.