CLINICAL OPERATIONS sutton

PERSONAL PROFILE

  • 30 years in medical and pharmaceutical arenas.

EXPERTISE

Cost Management, Process Improvement, Functional and Operational Efficiency, Strategic and Development Planning, Vendor Evaluation, Third Party and R&D Integration, Gap Analysis, Collaboration/Accountability/Decision-Making, CRO Partner Management.

PROFESSIONAL EXPERIENCE

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.