Clinical Outcomes Specialist
Job description
About the role
You will architect and maintain Leap's clinical outcomes measurement framework from the ground up, defining how adherence, safety, and patient-reported outcomes are captured for specialty infusion care. This position owns the core methodology that translates complex clinical data into clear evidence of value for patients, employers, payers, and manufacturer partners. You will establish the standards, logic, and validity benchmarks that ensure Leap's outcomes are both clinically rigorous and operationally meaningful. In this highly cross-functional builder role, you will operate comfortably within ambiguity and create essential processes where none previously existed. You will partner directly with Engineering to shape data capture structures, with Clinical Operations to embed workflows and patient engagement touchpoints, and with Manufacturer Partnerships to drive external evidence generation. Each measurement framework you build will directly support Leap's mission of delivering life-changing therapies with transparency and fairness in pricing. Your work will produce the immediate ROI that employers rely on through lower costs, improved access, and demonstrably better care for patients.
Key facts
What you'll do
- Architect Leap's outcomes measurement framework encompassing adherence, safety, patient-reported outcomes, and disease-specific clinical measures for specialty infusion therapy.
- Define metric definitions, denominator and numerator logic, inclusion criteria, calculation methods, and validity standards that withstand clinical and analytical scrutiny.
- Establish Leap's safety event taxonomy and reporting approach, covering infusion reactions, treatment interruptions, escalation events, near-misses, and other clinically relevant incidents.
- Lead the clinical review and quality assurance process to accurately capture safety events from clinical documentation and operational workflows, ensuring high-quality data integrity.
- Build patient-level adherence monitoring across therapies, conditions, and populations using infusion-specific methodology focused on persistence, schedule conformance, dose fidelity, treatment completion, and tolerability.
- Develop a risk-flagging process that identifies patients at elevated risk for treatment interruption or discontinuation by analyzing signals such as missed infusions, delayed authorizations, site-of-care disruptions, and medication access barriers.
- Select, adapt, and implement validated patient-reported outcome instruments appropriate for specialty infusion populations, ensuring clinical relevance and methodological soundness.
- Partner with Engineering and Clinical Operations to implement survey delivery workflows and structured response capture, integrating patient feedback into evidence generation.
- Analyze and interpret complex outcomes data to generate clinically defensible evidence of program impact, translating findings into actionable insights.
- Produce recurring outcomes reporting and evidence packages that support employer reporting, client QBRs, payer discussions, and manufacturer partnerships, demonstrating clear value.
- Align outcomes methodologies with recognized specialty pharmacy, home infusion, and quality measurement standards such as NHIA quality measures and other industry benchmarks where appropriate.
- Maintain comprehensive documentation of metric definitions, methodology updates, and the rationale for changes over time to ensure transparency and reproducibility.
- Generate recurring safety trend reports for clinical leadership, highlighting root-cause themes, emerging risks, and data-driven recommendations for process improvement.
- Partner with care teams to operationalize proactive outreach triggers for at-risk patients, ensuring timely interventions that support adherence and persistence.
- Establish measurement processes that connect clinical data sources, operational workflows, and patient engagement touchpoints into a cohesive evidence ecosystem.
Requirements
- Bring 3+ years of experience in specialty pharmacy, managed care, specialty therapeutics, home infusion, pharmaceutical outcomes, or specialty benefit management to this role.
- Apply direct experience with specialty disease states and specialty medication management within complex care settings.
- Demonstrate prior experience contributing to or owning a clinical outcomes, adherence, quality, or safety measurement effort in a healthcare environment.
- Show strong analytical capabilities, with the ability to define metrics, identify data sources, validate methodologies, and independently develop measurement applications.
- Exhibit comfort working with clinical, operational, and technical stakeholders to translate requirements into structured measurement frameworks.
- Understand the nuances of HCP-administered infusion therapy and the limitations of retail-pharmacy-based adherence measures like PDC or MPR for this population.
- Commit to maintaining rigorous standards for data quality, metric integrity, and clinical validity in all measurement activities.
- Communicate effectively in writing and verbally to present complex analytical concepts to diverse audiences including clinical teams, leadership, and external partners.
- Thrive in a fast-paced, mission-critical environment where ownership, precision, and follow-through directly impact program success.
Nice to have
- Leverage experience with NHIA quality measures or similar specialty pharmacy benchmarks to accelerate alignment with industry standards.
Practical notes
The role is US based remote; travel is not expected and visas are not sponsored. Work hours are typical business days with some flexibility for cross-team collaboration across time zones.
Compensation & Location
Location: US (Remote)
Engagement: Full-time
Compensation: $130,000 to $160,000 / Yrs