• Build and maintain Leap's outcomes framework across adherence, safety, patient-reported outcomes, and disease-specific clinical measures.
• Define metric definitions, denominator and numerator logic, inclusion criteria, calculation methods, and validity standards.
• Align outcomes methodologies with recognized specialty pharmacy, home infusion, and quality measurement standards where appropriate (e.g., NHIA quality measures and other industry benchmarks).
• Maintain clear documentation of metric definitions, methodology updates, and the rationale for changes over time.
• Define and stand up Leap's safety event taxonomy and reporting approach across infusion reactions, treatment interruptions, escalation events, near-misses, and other clinically relevant incidents.
• Own the clinical review and quality assurance process supporting accurate safety event capture from clinical documentation and operational workflows.
• Produce recurring safety trend reports for clinical leadership, including root-cause themes, emerging risks, and recommendations for process improvement.
• Build patient-level adherence monitoring across therapies, conditions, and populations.
• Define infusion-specific adherence methodology — persistence, schedule conformance, dose fidelity, treatment completion, and tolerability — rather than retail-pharmacy measures like PDC or MPR, which weren't built for HCP-administered infusion therapy.
• Build a risk-flagging process that identifies patients at elevated risk for treatment interruption or discontinuation, incorporating signals such as missed infusions, delayed authorizations, site-of-care disruptions, and medication access barriers.
• Partner with care teams to operationalize proactive outreach triggers for at-risk patients.
• Select, adapt, and implement validated patient-reported outcome instruments appropriate for specialty infusion populations where clinically appropriate.
• Partner with Engineering and Clinical Operations to implement survey delivery workflows and structured response capture.
• Analyze and interpret outcomes data to generate clinically defensible evidence of program impact.
• Produce outcomes reporting and evidence packages supporting employer reporting, client QBRs, payer discussions, and manufacturer partnerships.
