25+ years as life science drug developer in pharmaceutical and CRO settings that required strategic thinking, excellent communication, analytic veracity and timely project execution

Professional experience includes:

(Pharma) Health Economics and Outcomes Research (HEOR) Research Scientist
• Independently support clinical trials and execute HEOR projects
• Cross-functionally engage with clinical, trial managers, statisticians, brand, affiliate and regional staff, regulatory, payer and market access, medical and outcome liaisons, vendors, medical writing
• Execute systematic and targeted literature reviews
• Implement phase I through IV clinical trials; includes 5 registration studies
• Oncology tumor experience in solid (breast, lung, melanoma, ovarian) and hematologic (AML, multiple myeloma, NHL, myelofibrosis) and companion diagnostics
• Patient-reported outcomes (PRO) and utility measures: strategy, protocol writing, affiliate training, ePRO devices, analysis, study report and disclosures
• Provide HEOR content for global advisory boards and regulatory briefing documents
• Real-world evidence (RWE) gap analysis, protocol design, database analysis and publication
• Economic modeling; budget-impact models
• Launch excellence in multiple indications
• Generate value-based evidence for AMCP, health technology assessments
• Vendor engagement; budget management

(Pharma and CRO) Data scientist roles
• Collaborate on matrix team to optimize case report forms, edit definition and data analysis
• Train affiliates and investigator staff
• Data review and analytics; execution of interim and final data locks
• Identify and resolve issues: protocol deviations, patient eligibility, serious adverse events
• Data transfer of central lab data per client specification

(CRO) Corporate Liaison
• Resolve central laboratory issues for key client
• Organize central lab facility tours