Clinical Outcomes Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and uphold Leap's outcomes framework encompassing adherence, safety, patient-reported outcomes, and clinical measures specific to diseases.

• Establish definitions for metrics, logic for denominators and numerators, criteria for inclusion, calculation methods, and standards for validity.

• Ensure alignment of outcomes methodologies with acknowledged standards in specialty pharmacy, home infusion, and quality measurement when applicable (e.g., NHIA quality measures and other industry benchmarks).

• Keep comprehensive documentation of metric definitions, updates to methodologies, and the rationale for changes over time.

• Define and implement Leap's safety event taxonomy and reporting strategy covering infusion reactions, treatment interruptions, escalation events, near-misses, and other clinically significant incidents.

• Oversee the clinical review and quality assurance process to ensure accurate capture of safety events from clinical documentation and operational workflows.

• Generate regular safety trend reports for clinical leadership, highlighting root-cause themes, emerging risks, and recommendations for process enhancements.

• Create patient-level adherence monitoring across various therapies, conditions, and populations.

• Establish infusion-specific adherence methodologies—such as persistence, schedule conformance, dose fidelity, treatment completion, and tolerability—instead of retail-pharmacy measures like PDC or MPR that are not suited for HCP-administered infusion therapy.

• Develop a risk-flagging process to identify patients at increased risk for treatment interruptions or discontinuations, utilizing signals like missed infusions, delayed authorizations, site-of-care disruptions, and barriers to medication access.

• Collaborate with care teams to implement proactive outreach triggers for patients at risk.

• Select, adapt, and utilize validated patient-reported outcome instruments that are suitable for specialty infusion populations when clinically relevant.

• Partner with Engineering and Clinical Operations to execute survey delivery workflows and structured response capture.

• Analyze and interpret outcomes data to produce clinically defensible evidence demonstrating program impact.

• Create outcomes reporting and evidence packages to support employer reporting, client quarterly business reviews (QBRs), payer discussions, and collaborations with manufacturers.

⛳️ Requirements

• A minimum of 3 years of experience in specialty pharmacy, managed care, specialty therapeutics, home infusion, pharmaceutical outcomes, or specialty benefit management.

• Direct experience with specialty disease states and management of specialty medications.

• Proven experience contributing to or leading efforts in clinical outcomes, adherence, quality, or safety measurement.

• Strong analytical skills with the ability to define metrics, identify data sources, validate methodologies, and independently create measurement approaches.

• Experience in interpreting and ensuring the quality of structured clinical data from EHR, care management, or pharmacy systems.

• Capability to function effectively in ambiguous settings and build processes from foundational principles.

• Excellent written and verbal communication skills, with the ability to articulate methodologies and findings to both clinical and non-clinical audiences.

• PharmD, MPH, RN, or other relevant clinical or population health training is preferred.

🏝️ Benefits

• *At Leap, we are dedicated to offering competitive total rewards packages that include stock options and benefits. Individual compensation may differ from the target range and is influenced by various factors such as experience, location, internal pay equity, and other relevant business considerations.*