- Seasoned, global clinical operations executive with 30+ years of pharma experience.
Clinical Operations; Study/Project Management; Investigator Meetings, Site Selection and Qualification; Vendor/CRO RFP Development, Selection, and Oversight; Protocol/ICF/CRF/Study Report Development; Clinical Plans and Monitoring; Budgeting; Strategy; Leadership; Business Development; Global Acquisitions; Due Diligence; Vendor/Academic Relationships; Pharmacovigilance; Regulatory Document Collection and Submissions (global); Training; and Strategic Partnerships. Therapeutic Areas: Oncology (liquid and solid tumors, immunotherapy), Biotechnology (monoclonal antibodies, protein toxin), Cardiology, Devices, Gastroenterology, Gynecology, Hemophilia, Anti-Infectives (HIV/AIDS), Mega-trials, Neurology (epilepsy, MS), Respiratory, Smoking Cessation, Transplantation, and Wound Healing (burns, stasis ulcers).
B.S., Nursing, University of Kansas; graduate studies, Anatomy and Physiology, University of Kansas School of Medicine; B.G.S., Human Biology, University of Kansas.
Principal Consultant, Geiger Clinical Consulting
Provides Clinical Operations consulting to biopharmaceutical companies, including study and project management, and investigator selection. Performs vendor/CRO RFP development, selection, and oversight.
Helms global clinical operations department and personnel organizational reviews and candidate interviews, and contributes to protocol and ICF development. Develops budgets and clinical plans for funding purposes.
Executive Vice President and Head of Global Oncology, Clinipace Worldwide, Inc.
Oversee and provide strategy for Clinical Operations Division (US, Australia, and Latin America), manage clinical operations interactions with European division, and render executive oversight of start-up activities for Clinipace KK in Japan. As a member of Executive Management Team, developed and manage Oncology Therapeutic Business Unit, and train global staff (project management, GCP and ICH, drug development, and clinical operations).
Responsible for Business Development support, including input into proposal development and attendance at client meetings and proposal defense meetings. Provide global project management for selected clinical research programs. Qualify, select, and manage global partner CROs and vendors worldwide. Identify global acquisition targets and participate in due diligence activities. Manage academic and vendor relationships.
Organize and conduct investigator meetings, and investigator selection and qualification worldwide. Oversaw staff managing regulatory document collection and submission to health authorities. Develop protocols, CRFs, and study reports, and directed company pharmacovigilance activities on interim basis.
President, Worldwide Clinical Research, Inc.
Founder and President of multinational oncology-focused CRO responsible for all financial decisions, growth, and expansion until acquisition in October 2009 by Clinipace Worldwide. Oversaw all clinical trials, providing global project management for clinical research programs. Qualified, selected, and managed global partner CROs, managed academic and vendor relationships, organized and conducted investigator meetings, and selected and qualified investigators. Managed regulatory document collection and submissions to global health authorities. Developed protocols, CRFs, and study reports.
Director of Corporate Partnerships, Business Development, and Operations, PRA International
Developed business plan of new PRA International Initiative. Identified, qualified, negotiated agreements, and maintained relationships with potential partners in countries where PRA did not have locations. Identified and developed alliance plans for PRA Strategic Partners offering services outside of PRA core services. Directed business development efforts for site management organization, and developed plans for expansion of site management network and eventual divestiture of site management business. Oversaw day-to-day operations of the Charlottesville region, including supervising Project Managers, Investigator Recruitment center, and administrative personnel. Oversaw development, implementation, and monitoring of project plans and performance indicators by project teams.