Clinical Team
Michael J. Harte, MBA
President
Highly skilled professional with 24 years of sales, marketing, and senior management experience. Success has
been achieved in 3 different industries: office equipment (1985-1986), construction (1986-1992), and pharmaceuticals.
(1993-2022). Mike’s pharmaceuticals expertise has been achieved as a pharmaceutical representative and business developer for service organizations supporting clinical drug development. Results-oriented performer in achieving or succeeding goals. Strong abilities as a problem-solver who can identify creative solutions. Team-oriented motivator who functions very successfully within a team or organization. Ability to align with all levels of an organization, from senior management through line workers. Strong mediation skills between two parties to achieve successful endpoints. Personable, honest, and hard-working. Credible within the industry for knowledge, teamwork, meeting and exceeding goals. Bridge relationships and cross-functional teams on a domestic and international level.
James Kirwin
Biopharma Executive
Pharmaceuticals ~ Biotechnology ~ Medical Devices ~ Phase I-IV Clinical Trials ~ Clinical Operations & Project Management
Results-driven senior BioPharma Clinical Operations executive with MBA and track record of success with global industry leaders (Pfizer, Wyeth, AstraZeneca) as well as niche / startup businesses (in-house and as consultant). Extensive experience developing and overseeing distributed high-performance teams (internal, external, CRO) in execution of strategic plans to integrate company / product / staff acquisitions, consolidations and integrations, INDs, and product launches. Development experience in small molecules, monoclonal antibodies, vaccines, Cell and immunotherapy. Early experience in hands-on clinical research.
