- 40+ years in medical and pharmaceutical arena.
Strategic and Development Vision and Planning, Product Development, Clinical Operations Leadership, Cost/Program Management, Process Improvement (Functional/Operational Efficiency), Third Party and R&D Integration, CRO/Vendor Management/Evaluation, KOL Relationships, Gap Analysis, Clinical QA, Internal Study Audits, Sponsor/ Medical/Clinical Scientific Liaison, Inspection Readiness and Rapid Submissions, Collaboration/Accountability/ Decision-Making, Employee Retention, Resource Leveraging, Quick and Cost-Effective Results, Nurse Practitioner, and Motivational and Presentations Skills. 10 Publications and Presentations.
- Founder and Principal, Professional Clinical Consultants, LLC
Consults pharma and biotech industry (focus on immune-oncology, oncology, rare diseases, and COVID-19) to develop operational and cost efficiencies in implementing compound development locally, globally, and virtually. Works with/ across all R&D functions to drive process improvement to enhance team collaboration and accountability, improve decision-making, streamline or create processes, and evaluate and mitigate risk for real cost savings. Performs clinical audit preparation, gap analysis, and response to enhance quality processes and documentation. Expert in clinical operations leadership; post-merger process integration; compliance remediation; inspection readiness and rapid submissions; BLA submission oversight; and creating, developing, and maintaining clinical operations groups in pilot-to-Phase 4 development. Experienced in CRO and 3rd party selection, management, and evaluation; KOL relationships; and oversight of reference model TMF best practices. Ensures tactical, strategic sustainability and scalability of business processes, and institution of a culture of quality across all functions. Recent assignments include:
- Prepared biotech sponsor company for inspection readiness prior to NDA submission with a Clinical QA gap analysis and internal study audits to develop needed processes.
- Sponsor Liaison between sponsor/CRO/third-party vendors for COVID-19 treatment development to realize greater operational/cost efficiencies and drive clinical QA to ensure inspection readiness and rapid submission of EUA.
- Oversaw FDA-required additional data collection and BLA submission in a rare disease.
- VP Clinical Operations overseeing Phase 1 trial, leading vendors/CRO partner for Phase 2, and growing in-house clinical operations group.
- Medical/Clinical Scientific Liaison for rare disease Phase 2 development: achieved 200% increase in enrollment immediately and sustainably.
- Interim VP Clinical Operations overseeing global functions; developed a TMF with QA and IT from scratch, drove clinical inspection readiness, and functioned as Clinical Operations SME during EMA inspection.
Vice President, Clinical Operations, Galena Biopharma, Inc.
Led and managed successful Clinical Operations team. Responsible for hiring, staff training/development, and retention. Managed 700-patient global trial in 13 countries, two CROs, and multiple outsource vendors for cancer immunotherapy NeuVax. Achieved cost and operational efficiencies of approximately $75K. Identified and developed pathway for a companion diagnostic, interfacing with CBER and CDRH. Worked with regulatory to develop a GCP training plan and training record system. Represented Galena in professional interactions (KOL, FDA, and scientific meetings/forums).
Vice President, Clinical Services, Allos Therapeutics, Inc.
Oversaw clinical operations, medical writing, data management, and outsourcing groups. Participated in development planning of the Folotyn franchise, a non-Hodgkin’s lymphoma drug. Delivered $500K cost savings on a large Phase 3 global trial (anticipated savings of $1.5M over five years). Reviewed and consolidated contracts to save approximately $100K/year. Initiated and led R&D cross-functional gap analysis to improve compliance and standardize controlled document and work instruction.
Senior Director, Research Operations and Strategic Development Liaison, RPS, Inc.
Provided strategy to leadership to improve proposal responsiveness, opportunity development, and industry presence. Established resource allocation algorithms to increase operational and internal cost efficiency and accuracy, and customized solutions for clients for efficiencies, flexibilities, and control.