Market Access Director

Director, Market Access

Company: PolarityBio

Status: Full-time, exempt

Location: Remote (North America)

About PolarityBio and SkinTE

PolarityBio is a late-stage biotechnology company preparing to launch SkinTE, an investigational product in an entirely new category: regenerative multicellular biologics. SkinTE is made from the patient's own skin — a small piece of healthy tissue is processed into autologous cutaneous multicellular units that retain the cell populations and architecture of native skin, then applied to the wound, so the therapy works with the patient's own biology.

SkinTE is under FDA review as a physician-administered Section 351 biologic (BLA) in the treatment of chronic wounds, with the anticipated first indication Wagner 1 diabetic foot ulcers.

Role Summary

The Director, Market Access owns the coding, coverage and payment strategy that will make SkinTE accessible to providers and patients at launch and beyond. This is a hands-on leadership role centered on payer strategy — coverage, payment, and payer contracting — supported by Medicare Administrative Contractor (MAC) engagement, reimbursement operations, vendor oversight, and leadership of the field reimbursement team. This leader both sets the access strategy and leads it, with support from specialist vendor partners on execution. As a physician-administered biologic reimbursed under the buy-and-bill model, SkinTE requires a leader who understands ASP-based payment, provider economics, and SkinTE's parallel coding pathways — Category III CPT codes (1044T–1049T) for the harvest and application procedures, and a product-specific HCPCS Level II J-code for the biologic.

This role works closely across Commercial, Medical, Regulatory, and Legal, and carries real influence over launch readiness.

Key Responsibilities

Payer strategy, coverage, and payment

• Develop and execute the national and regional payer strategy across Medicare, Medicaid, and commercial channels, with accountability for both 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 the Category III CPT codes (1044T through 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 for the organization.
• Lead pre-approval information exchange (PIE) with payers, formulary committees, and similar entities, consistent with FDA guidance and applicable law on manufacturer communications with payors, and transition to health care economic information (HCEI) communications after approval, leveraging vendor partners as needed.

• Support the coding strategy across 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.

Vendor partnerships and field reimbursement

• Build and lead field reimbursement capability — in-house, vendor-supported, or a blend — based on the needs of the providers and field team.
• Serve as the escalation point for complex coverage, coding, prior authorization, and site-of-care billing questions.
• Develop reimbursement tools, training, and resources that equip field and provider-facing teams to communicate coverage and access accurately and compliantly.

• Select and manage market access vendors to support execution — including coding, payer research and contracting support, dossier development, field reimbursement, and hub/patient support — setting scope and priorities and holding them accountable to service levels, compliance standards, and disciplined use of spend.

Required Qualifications

• Bachelor's degree required. Advanced degree (MBA, MPH, PharmD, or equivalent) preferred.
• 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 to deliver results, 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.

Preferred Qualifications

• 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 CAT III codes
• Experience building, leading, or closely managing a field reimbursement or access team.
• Experience standing up patient support or hub programs.