Director / Senior Director, Market Access & Reimbursement

Job description

**About Us** DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA. In our passionate pursuit to radically improve health outcomes, we serve humanity when we: **Lead with Science, Anchor in Pragmatism**: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction. **Build With & For All**: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class **Put We over I**: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey. **DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD offices** ### About the Role As DELFI's dedicated Market Access & Reimbursement leader, you will own and build the U.S. access strategy for DELFI's product lines end to end. You will translate DELFI's clinical and health-economic evidence into coding, coverage, and payment strategy that put our early cancer detection products into patient care. This is a hands-on, player-coach role in which you will set strategy and execute it by prioritizing your engagements across working directly with CMS/Medicare, and/or MACs, and priority regional, integrated, and federal payers. Deep, current CMS/Medicare expertise is the center of gravity for this role. Over time, you will build out the function and the team beneath it. This role operates within DELFI’s compliance framework separating non-promotional scientific exchange from commercial/reimbursement activity; external stakeholder engagement is coordinated with Legal/Compliance. ### What You'll Do - Own and execute DELFI's U.S. market access and reimbursement strategy across product lines, from coding and coverage through payment. - Serve as DELFI's subject-matter expert on CMS/Medicare, including Medicare Administrative Contractors, LCD/NCD processes, MolDX, and the ADLT, gapfill, and crosswalk pricing pathways relevant to novel diagnostics. - Develop and drive coverage strategies with priority payers, including Medicare, regional and integrated payers, and the VA. - Build formal strategic reimbursement plans for new product launches, including evaluation of coding, coverage, and payment options and innovative alternative payment models. - Partner cross-functionally with Medical Affairs, Clinical, Commercial, Regulatory, and Health Economics to align evidence generation with payer requirements and minimize utilization-management restrictions. - Partner with Legal/Compliance to ensure all engagement with payers, professional societies and KOLs complies with applicable law and industry codes, maintaining a clear distinction between non-promotional scientific exchange and commercial/reimbursement activity. - Identify health-economic evidence gaps and translate payer evidence needs into cross-functional study and dossier requirements. - Engage external stakeholders, including payers, health technology assessment bodies, professional societies, and KOLs, to shape favorable coverage policy in coordination with Commercial leadership on downstream adoption and utilization. - Establish the foundational tools, processes, and consultant and advisor network for a scalable market access function, and build the team as the function grows. ### What You'll Bring **Required** - Bachelor's degree with 12+ years (Director) or 15+ years (Senior Director), or Master's or advanced degree with 10+ or 12+ years of market access and reimbursement experience in diagnostics, medical devices, or pharma. Level will be set at offer based on depth of experience. - **Deep, current expertise in CMS/Medicare**, including coverage and payment pathways, Medicare Administrative Contractors, LCD/NCD processes, MolDX, and diagnostic-specific pricing mechanisms such as ADLT, gapfill, and crosswalk. - Demonstrated track record securing coverage and payment with CMS and U.S. commercial payers, ideally including regional, integrated, and VA or federal payers. - Expertise in coding classification systems (CPT, HCPCS, ICD-10) and payer policies governing billing and compliance. - Proven ability to build strategy and execute hands-on as a sole functional owner, with the resourcefulness to operate without a team initially. - Excellent communication, presentation, and influencing skills, with a demonstrated ability to reconcile multiple stakeholder views and negotiate matters of significance with senior internal and external leaders. **Preferred** - Experience in molecular diagnostics, genomics, or multi-marker 'omic assays, or in early cancer detection. - Experience building or scaling a market access function from an early stage. - Direct experience with health technology assessment bodies and professional-society guideline strategy. - An advanced degree in public health, public policy, health economics, political science, or business.