- 36 years in medical and pharmaceutical arenas.
Cost & Program Management, Product Development , Process Improvement, Enhanced Functional and Operational Efficiency, Strategic and Development Planning, Vendor Evaluation, Third Party and R&D Integration, Gap Analysis, Program Oversight, Collaboration/Accountability/Decision-Making, CRO Partner Management, Vendor Evaluation, Building KOL Relationships, Leveraging Resources, Delivering Rapid, Cost-Effective Results, Motivational and Presentations Skills. 10 Publications and Presentations.
Founder and Principal, Professional Clinical Consultants, LLC
Provides strategic, operational, and financial consulting for early through Phase 4 development for pharma, biotech, and full service CROs with focus on optimizing results in clinical product development domestically, globally, and virtually. Delivers strong clinical research and operations experience exclusively in life sciences, with extensive expertise in program oversight. Applies best practices to leverage internal and external resources to enable rapid and cost-effective results through continual process improvement.
Vice President, Clinical Operations, Galena Biopharma, Inc.
Turned around a struggling 700-patient NeuVax trial. Managed two CROs, multiple outsource vendors, and integration of new CRO. Opened 130 sites in 13 countries globally while strengthening CRO vendor performance. Saved $75K per year in vendor costs. Identified and developed pathway for a companion diagnostic; interfaced with CBER and CDRH to come to a development agreement.
Vice President, Clinical Services, Allos Therapeutics, Inc.
Delivered $500K cost savings on a large Phase 3 global trial, with anticipated savings of approximately $1.5M over five years. Initiated and led R&D cross-functional gap analysis to improve compliance across R&D organization. Improved communication and meeting efficiency to eliminate silos. Transferred clinical operations responsibilities during “integration” process; conducted large clinical process/gap analysis and document audits.
Senior Director, Research Operations and Strategic Development Liaison, RPS, Inc. – Clinical Development Solutions Company
Expanded business unit by providing the clinical, operational, and scientific/medical expertise during RFP response and bid-defense processes. Provided strategy to executive and functional leadership to improve proposal responsiveness, opportunity development, and industry presence.
Vice President, Clinical Operations, Sagemed (Formerly Medrock)
Wrote and delivered presentations for client and speaker meetings. Represented client to FDA during submission meetings. Drafted updated clinical operations and proposal reports for board meetings.
CEO, President Clinical Programs
Director, Clinical Safety and Clinical Development, Cortech, Inc.
Senior Clinical Research Associate, CRA Field Manager, The Institute for Biological Research and Development
Medical Research Associate, Clinical Research Department Project Manager, Schering-Plough Corporation
Nurse Practitioner, Clinical Coordinator and Clinic Research Coordinator, Congestive Heart Failure Clinic, Minneapolis Heart Institute Foundation
Critical Care Nurse and Cardiovascular Nurse Practitioner