CLINICAL AND RESEARCH OPERATIONS
- 30 years in medical and pharmaceutical arenas.
Clinical Operations and Research, Operational Planning and Management, Protocol Development, Pharmaceutical Drug Development (Phases 1 – 3), Regulatory Compliance, Quality Assurance, Program Management, Strategic Planning/Development/Implementation, CRO Oversight, Cost/Resources/Budget Maximization, Vendor/Clinical Supplies Management, e-CTD Submissions and Documentation, Biotech Startups, Presentation and Report Writing, Collaboration/Accountability/Decision-Making, Recruitment/Mentoring/Team Management, Critical Care Nursing. Clinical Expertise: Sepsis, Acute Respiratory Distress Syndrome, Multiple and Head Trauma, Acute Pancreatitis, Inflammatory Bowel Disease, Non-Insulin-Dependent Diabetes, AIDS, Kaposi’s Sarcoma, Pancreatic CA, Irritable Bowel Syndrome, Parkinson’s, Epogen Comparator/Drug Accountability, COPD, Oral Mucositis, Head and Neck Cancer, Bone Marrow Transplant, Asthma, Cystic Fibrosis, Combination Drug/Device, Catheter Locking Solution, Lacrimal Diversion Device.
Senior Research Consultant, Research Operations, Microdermis, Inc.
Collaborate in project planning, budgeting, and resources and contract research organization (CRO) management for dermal product manufacturing. Guide and direct all research operations, planning, and management.
Executive Director, Clinical Operations, Sinopsys Surgical, Inc.
Responsible for early clinical development of device to treat chronic sinusitis and obstructive or functional epiphora. Collaborated in project planning, budgeting, and resources and CRO management. Guided and directed all research operations, planning, and management.
Executive Director, Senior Director, and Director, Clinical Operations, N30 Pharmaceuticals, Inc.
Controlled a first-year budget of $3 million. Hired all clinical staff. Collaborated in project planning, budgeting, and resources and CRO management. Directed all research operations, planning, and management. Ensured regulatory compliance and validity. Developed standard operating procedures (SOPs), infrastructure, and clinical protocol for drug development, and extensive e-CTD submissions and document management.
Senior Research Consultant, Clinical Development, Great Lakes Pharmaceuticals, Inc.
Managed vendors, clinical supplies, and quality oversight. Designated Unblinded Sponsor Representative.
Director, Associate Director, Clinical Operations, Endo Pharmaceuticals, Inc./RxKinetix, Inc.
Oversaw clinical operations planning, development, and management. Ensured regulatory compliance and validity. Selected and managed CROs, budgets, and time lines for clinical programs and performance requirements. Developed SOPs and departmental infrastructure for clinical programs. Served key role in palliative care product development for treating oral cancer, from early Phase 1 to successful completion of Phase 2 meetings with FDA.
Clinical Manager, Associate Director, Clinical Research, Source Precision Medicine, Inc.
Developed, implemented, and monitored human clinical research using gene expression analysis in preclinical and therapeutic applications. Created infrastructure, regulatory standards, and SOPs for clinical studies.
Founder/Consultant, Clinical Connection, Inc.
Led a consultancy practice specializing in clinical research monitoring and project management for biotech and pharmaceutical companies, including British Biotech, Novartis, SmithKline Beecham, Pfizer, and others. Orchestrated concurrent clinical studies for two protocols at up to 30 sites.
Clinical Research Associate II, Project Lead, Cortech, Inc.
Monitored Phase 3 sepsis study. Served as project manager for head trauma, ARDS, and multiple trauma studies with bradykinin antagonist compound.
Director of Nursing, Vencor Hospitals, Inc. and Maxim Home Healthcare Services