Senior Director Medical Affairs - HEOR
Kardigan · Princeton, NJ · 3 wk ago
Healthcare$263k–$385k/yrFull-time
Essential Duties and Responsibilities
- Scope the cost and utilization analyses, economic models, and evidence syntheses each program needs across development and launch, and sequence them against value and access milestones.
- Prioritize the value and access questions that most affect payer, provider, and health-system decisions, and convert them into concrete analysis and deliverable plans.
- Personally execute costing, resource-use, and economic-outcomes analyses on claims and linked clinical–claims data, applying unit costs and valuation methods to estimate cost-of-illness, cost consequences, and budget impact for target populations.
- Analyze utilization and economic outcomes (i.e., hospitalization and 30/90-day readmissions [DRG-level and condition-related], treatment and procedure costs, and pre-/post-procedure care such as AVR/TAVR) to produce the cost inputs, offsets, and economic endpoints that feed models and value claims.
- Build the direct- and indirect-cost picture from the data, scoping economic and utilization endpoints (and clinical outcomes only insofar as they drive cost).
- Scope, specify, and own the portfolio's economic models (i.e., cost-effectiveness and cost-utility [Markov, microsimulation, discrete-event simulation, or decision-tree], budget-impact, and cost-of-illness) including structure, assumptions, and the value case each model makes.
- Commission and manage model build by internal modelers or external vendors, and critically appraise, validate, and stress-test results (sensitivity, scenario, and/or value-of-information analysis) before they inform pipeline, pricing, and value decisions.
- Specify and appraise key model inputs [i.e., treatment effects, health-state utilities and preference weights [e.g., EQ-5D, mapping clinical measures to utilities], costs, resource use, and transition/event probabilities) sourced from trials, literature, real-world data, and Epidemiology-led analyses.
- Oversee localization of global models for specific payer and reimbursement settings, and ensure models stay transparent, auditable, documented, and defensible to payers and HTA bodies.
- Direct indirect treatment comparisons, network meta-analyses, and matching-adjusted indirect comparisons (commissioning execution internally or via vendors and critically appraising methods and results) to provide the relative-effectiveness and comparator inputs models require where head-to-head data are missing.
- Define the comparator and standard-of-care assumptions for models and value claims, drawing on treatment-pattern evidence supplied by Epidemiology.
- Scope and quality-assure targeted and systematic literature reviews that anchor model parameters and value propositions in the published evidence base.
- Produce the value deliverables (value propositions, AMCP-format and global value dossiers, payer/HTA evidence packages, and objection-handling materials) that convey clinical and economic value in a strictly non-promotional manner.
- Support pricing, reimbursement, and formulary work, including post-loss-of-exclusivity pricing research, and build and evaluate the economic case for outcomes-based and value-based contracts.
- Package economic and outcomes findings into evidence and tools tailored to payers, providers, and health-system decision-makers.
- Specify the HEOR-specific data needed for analyses and models (linked clinical-plus-cost/utilization content [claims, linked EHR–claims, payer/encounter, DRG-level]) with the coverage, linkage, currency, and exportability each analysis requires.
- Vet candidate datasets and vendors for fit against those requirements, contribute recommendations to the cross-functional sourcing process, and secure analysis-ready data that can be reused across value questions.
- Deliver in close partnership with Clinical Development, Commercial, Pricing, Epidemiology, Data Science / Applied ML, Business Development, and Finance, and engage Legal, Compliance, Privacy, and Quality to keep economic evidence and data use compliant and non-promotional.
- Turn analyses into peer-reviewed manuscripts, congress presentations (e.g., ISPOR, AMCP), and value dossiers, and represent the economic evidence with external experts, payers, and health systems.
Qualifications and Preferred Skills
- Doctoral degree in health economics, outcomes research, pharmacoeconomics, health services research, health policy, or a related field (PhD, ScD, DrPH), or a PharmD/MD with HEOR or health-economics fellowship training.
- 12+ years generating HEOR and value evidence in biopharma, consulting, academic, or comparable settings, including hands-on real-world data analysis of cost, utilization, and economic outcomes.
- Direct, hands-on experience across the real-world dataset types relevant to cost and utilization (including administrative claims [commercial, Medicare fee-for-service, Medicare Advantage, Managed Medicaid, etc.], linked EHR–claims, hospital cost/charge and encounter [DRG-level] data, and registries) with working command of their respective cost-capture, coverage, and linkage strengths and limitations.
- Demonstrated hands-on execution of costing, resource-use, and economic-outcomes analyses on claims and linked clinical–claims data with strong proficiency in SAS, R, and/or SQL.
- Ability to scope, specify, critically appraise, and validate decision-analytic and economic models (cost-effectiveness/cost-utility, budget-impact, and cost-of-illness).
- Working command of evidence-synthesis and relative-effectiveness methods (indirect treatment comparison, network meta-analysis, matching-adjusted indirect comparison) and of health-state utility and preference valuation.
- Fluency in market access, payer, HTA, reimbursement, and value-communication expectations (e.g., AMCP dossiers, ISPOR good-practice standards), including outcomes-based contracting.
- Grasp of data privacy and compliance (e.g., HIPAA) and of the non-promotional rules governing economic and value evidence.
- A record of delivering through matrixed, cross-functional teams.
- Cardiovascular therapeutic-area background (e.g., heart failure, hypertension and hypertensive crisis, cardiomyopathy/DCM, valvular and aortic stenosis).
- Hands-on economic-model building experience (e.g., Excel, R, TreeAge).
- Experience folding economic and resource-use endpoints into clinical trials and turning trial data into value evidence.
- Exposure to global HTA submissions and payer systems (e.g., NICE, HAS) alongside US payers and integrated delivery networks.
- Hands-on design or evaluation of value-based and outcomes-based contracts.
- Early-stage and pipeline economic modeling that informs portfolio prioritization and business-development decisions.
- Experience selecting and managing external data vendors and analytics partners and assembling reusable value-evidence assets.
- A solid publication and congress-presentation record in HEOR, health economics, or outcomes research.
- Comfort delivering in a matrixed setting.
Exact Compensation may vary based on skills, experience and location.