Consultant
Disclosure(s): Iterum Therapeutics: Board Member, Employee, Stocks/Bonds (Public Company)
I am a founder and Chief Scientific Officer of Iterum Therapeutics, a venture backed, clinical stage biotechnology company developing sulopenem for the treatment of gram negative infections, responsible for establishing our manufacturing supply chain, developing and executing our clinical and regulatory development strategies and investigating new technologies and products aligned with our lead candidate.
I was a founder and the Chief Medical Officer of Durata Therapeutics, Inc, and along with the Chief Executive Officer, Chief Operating Officer and Chief Commercial Officer, I was an integral part of the corporate leadership team defining business strategy for the development of dalbavancin, a long-acting intravenous glycopeptide for the treatment of serious infections due to methicillin resistant staphylococci. I was responsible for the development and successful global registration of dalbavancin leading to an NDA and MAA. In this role I was responsible for Clinical Development, Clinical Operations, Global Regulatory Affairs, Global Quality Assurance, and Medical Affairs.
At the Gates MRI I was the Head of Development and Chief Medical officer responsible for clinical trials in therapeutic areas aligned with the mission of the Gates Foundation.
While at Pfizer, I was responsible for the strategic and operational oversight of the clinical Infectious Diseases portfolio from first in patient through first and supplemental regulatory approvals, working in collaboration with Commercial and Research Therapeutic Heads. In this capacity, I was responsible for development and execution against 1, 5 and 10 year strategic plans and progression of the in-line portfolio as well as assuming a leadership role in licensing and acquisition activities.
Specific responsibilities included input and oversight of all aspects of protocol and clinical program design, matrixed responsibility for all regulatory interactions and management responsibilities for approximately 70 members of Infectious Diseases Therapeutic Area.
The portfolio at Pfizer included antifungal agents, antibacterial agents, vaccines, therapy for treatment and prevention of malaria, and antiviral projects, including drugs to treat HIV and HCV infection.