Director, Health Economics Outcomes Research (HEOR) and Real World Evidence (RWE)
Passionate about precision medicine and advancing the healthcare industry?
Here, you will be a vital contributor to our inspiring, bold mission. Immerse yourself in the tough problems we’re solving, and team with commercial markets, market access, medical affairs, regulatory, R&D, product, and various other cross-functional teams to help us do so.
The Health Economics and Outcomes Research (HEOR) and Real World Evidence (RWE) Director will help shape Tempus’ clinical evidence development strategy to define the plan, perform data analysis, and communicate results to various stakeholders (including the Food and Drug Administration (FDA), Center for Medicare & Medicaid Services (CMS), private payers, and the U.S. Preventive Services Task force (USPSTF)) with the end goal of achieving broad coverage and favorable reimbursement for Tempus’s products. This role will collaborate heavily with internal and external HEOR stakeholders to include key opinion leaders (KOLs) to address government, provider, payer, and internal company HEOR needs. This position will work cross-functionally to tailor clinical endpoints and messaging appropriately to the applicable stakeholders, effectively communicating and presenting complex technical concepts and quantitative analyses to both internal and external executive audiences. This role establishes plans with expertise in the design and application of clinical evidence generation projects during all phases of product life cycles, including premarket approval (PMA) submissions and early lifecycle coverage determinations.
Responsibilities:
- Direct RWE strategy; including, but not limited to, creating end points to address market needs, data management, and registry protocol
- Work cross-functionally with key internal stakeholders; including, but not limited to, commercial markets, market access, regulatory, provider relations, medical affairs, business development, product development, data science, and finance and with key external stakeholders; including, but not limited to, patients, providers, economists, payers, healthcare organizations, and policymakers to define specific customer needs and drive the RWE generation strategy accordingly
- Manage cross-functional teams to execute and deliver research, projections, and analyses on a project basis, as needed
- Lead the development of HEOR strategies; assist in the creation of tactics for economic value and quality of life arguments during product development, launch, and post-launch to support pricing and reimbursement across payer and health system customers
- Educate the organization continually on the latest developments in HEOR as it relates to; including, but not limited to, evidence-based medicine, the regulatory processes, and reimbursement policies
- Develop research plans, protocols, and budgets; conduct analyses and prepare drafts, final reports, abstracts, and manuscripts
- Incorporate business requirements and concerns of top tier customers and KOLs into RWE strategies, analytic tools, and results-focused approaches
- Identify and maintain successful research relationships with HEOR KOLs and other clinical and/or academic consultants
- Facilitate value- and outcomes-based evaluations in support of contracting with payer organizations.
- Provide additional internal training on HEOR methodologies and data results to colleagues
- Work closely with medical writers and analysts to ensure analysis and scientific material is appropriate, relevant, and accurate
- Ensure compliance with applicable standard operating procedures (SOPs) in all activities.
Qualifications
Minimum
- Ph.D. in Health Economics, Outcomes Research, Epidemiology, or field as outlined in the responsibilities of the position; or Master’s Degree with 4+ years of relevant experience as outlined in the essential duties in lieu of Ph.D
- Demonstrated progressive advancement in relevant pharmacoeconomics or professional roles in the pharmaceutical or biomedical industry, a managed care, public sector, academic organization, HEOR research organization, or other setting in which responsibilities included population-based healthcare management and/or clinical/pharmacoeconomic evidence generation
- Demonstrated strong knowledge of and comfortability with various aspects of effective RWE generation and implementation to include the management of consulting relationships, clinical registry management, protocol design, oversight of data collection and/or acquisition, analytic plan development, data analysis, KOL engagement, and the development of research findings into publications and field resources/deliverables in alignment with product and channel strategies
- Demonstrated familiarity with methodological approaches and tools in health services research to include retrospective database analysis, cost-effectiveness analysis, budget impact models, modeling studies, and/or patient reported outcomes assessment.
- Strong knowledge of the U.S. healthcare system and the reimbursement processes/decision making
- Thorough knowledge of U.S. data sources and payer claims; demonstrated ability to maintain a strong understanding of the evolving U.S. healthcare environment and implications for HEOR strategy
- Ability to think creatively and innovatively about HEOR approaches to a brand-new multi-cancer diagnostics market.
Preferred
- 10+ years of experience in health economics, outcomes research, pricing, or reimbursement related to new healthcare interventions.
- 2+ years of experience managing RWE strategy for new healthcare interventions to include the creation of end points to address market needs, data management, and registry protocol.
- 2+ years in the pharmaceutical or biomedical industry to include a demonstrated history of excellent performance success supporting products that are early in their life-cycle.
#LI-SH1