Market Access Director
About The Position
PolarityBio is a late-stage biotechnology company preparing to launch SkinTE, an investigational regenerative multicellular biologic made from a patient’s own skin. SkinTE is under FDA review as a physician-administered Section 351 biologic (BLA) for chronic wounds, with an anticipated initial indication of Wagner 1 diabetic foot ulcers. The Director, Market Access owns the coding, coverage, and payment strategy to support provider and patient access to SkinTE at launch and beyond. This hands-on leadership role focuses on payer strategy, coverage, payment, and payer contracting, and also includes Medicare Administrative Contractor engagement, reimbursement operations, vendor oversight, and leadership of the field reimbursement team. The director sets and leads the access strategy, with specialist vendor partners supporting execution. The role requires understanding ASP-based payment, provider economics, and SkinTE’s parallel coding pathways: Category III CPT codes 1044T–1049T for harvest and application procedures, and a product-specific HCPCS Level II J-code for the biologic. The director works closely with Commercial, Medical, Regulatory, and Legal and has significant influence over launch readiness. The role is full-time, exempt, and remote in North America, with travel as needed for payer, provider, and conference engagements.
Requirements
- Bachelor’s degree required.
- Direct experience with BLA biologics and/or physician-administered (buy-and-bill) pharmaceuticals, including ASP-based reimbursement and provider economics.
- Demonstrated success securing coverage and payment through MAC engagement.
- Experience owning payer strategy and contracting across commercial and government channels.
- Demonstrated success leading external market access vendors and agencies, including scoping, budget management, and performance accountability.
- Strong working command of MLR and compliance requirements in a promotional environment.
- Experience at a small or launch-stage company where the role spans strategy and execution.
- Willingness to travel as needed for payer, provider, and conference engagements.
Nice To Haves
- Advanced degree (MBA, MPH, PharmD, or equivalent).
- Experience in wound care, diabetic foot ulcers, or advanced wound therapies.
- Launch experience with a first-in-class or newly coded product, including work on Category III codes.
- Experience building, leading, or closely managing a field reimbursement or access team.
- Experience standing up patient support or hub programs.
Responsibilities
- Develop and execute national and regional payer strategy across Medicare, Medicaid, and commercial channels, accountable for coverage and payment outcomes, including ASP-based payment dynamics and provider economics.
- Lead payer contracting.
- Lead MAC engagement to secure favorable coverage and pricing for Category III CPT codes 1044T–1049T, Local Coverage Determinations, and the evolving skin substitute payment policy landscape.
- Monitor CMS policy, OPPS and MPFS updates, and coding cycle timelines, and translate them into launch and pricing implications.
- Lead pre-approval information exchange (PIE) with payers, formulary committees, and similar entities consistent with FDA guidance and applicable law, then transition to health care economic information (HCEI) communications after approval, using vendor partners as needed.
- Support coding strategy throughout the product lifecycle, relying on vendor partners for execution and submissions.
- Partner with Medical Affairs and HEOR to align evidence generation with coverage and payment requirements.
- Build and lead field reimbursement capability, in-house, vendor-supported, or blended, based on provider and field-team needs.
- Serve as the escalation point for complex coverage, coding, prior authorization, and site-of-care billing questions.
- Develop reimbursement tools, training, and resources so field and provider-facing teams communicate coverage and access accurately and compliantly.
- Select and manage market access vendors supporting coding, payer research and contracting, dossier development, field reimbursement, and hub/patient support; set scope and priorities and ensure service-level, compliance, and spending accountability.
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What This Job Offers
Job Type
Full-time
Career Level
Director
