Director, 340B Pharmacy Operations (Remote)

Job Overview:

The Director, 340B Pharmacy Operations serves as the operational and compliance lead for Coral's 340B Infusion Leakage Program. This role owns the full lifecycle of 340B program delivery, from internal quality assurance framework design and HRSA registration validation, through go-live onboarding, policy development, and ongoing compliance auditing. The incumbent acts as the primary subject matter expert for covered entity partners and infusion providers ensuring program integrity, financial accuracy, and regulatory adherence at every stage.

Responsibilities:

Your key responsibilities will include:

• Design, implement, and maintain Coral's internal 340B quality assurance and compliance framework across all program workflows, including but not limited to:
  • 340B eligibility validation, accumulator alignment, and financial integrity oversight.
  • Lead pre- and post-bill reviews to identify and resolve discrepancies before and after claim submission.
  • Conduct monthly and quarterly compliance audits across covered entity and infusion provider sites; document findings and drive corrective action plans.
  • Perform cross-entity workflow validation, reinforcing consistency, and ongoing oversight across all partner sites.
  • Develop and maintain KPI and quality reporting dashboards for internal leadership and covered entity partners.
• Provide HRSA registration and regulatory oversight including but not limited to:
  • Validate all covered entity HRSA OPAIS registration steps prior to 340B dispensing, including infusion provider contract pharmacy site linkage and quarterly registration window coordination.
  • Advise hospital partners on Medicaid carve-in vs. carve-out strategy for infusion provider sites.
  • Confirm AIC sites are live and active in OPAIS before any 340B dispensing commences; track registration approvals and flag delays affecting go-live timing.
  • Ensure compliance with all foundational HRSA patient eligibility requirements: established patient status, hospital-employed or contracted provider, hospital-written infusion orders, and infusion documentation incorporated into the hospital EHR.
• Lead end-to-end program onboarding and implementation, including planning, stakeholder alignment, and execution across all workstreams, including but not limited to:
  • Facilitate joint kickoff sessions with health system and infusion provider stakeholders (both onsite and virtual), clearly outlining financial models, implementation plans, roles, and accountability.
  • Develop and maintain a comprehensive SOP library ensuring standardization across key workflows (referral/eligibility, order processing, inventory controls, billing, and audit response)
  • Direct training strategy and delivery across all stakeholder groups (clinical, pharmacy, billing, inventory, and 340B program staff), ensuring readiness and adherence to program requirements
  • Manage pre-go-live testing and implementation execution, proactively identifying risks, managing timelines, and ensuring successful program launch
• Provide ongoing managed services, including but not limited to:
  • Oversee ongoing 340B eligibility integrity monitoring and TPA data reconciliation.
  • Maintain record-keeping systems and coordinate audit cooperation for covered entity compliance audits.
  • Lead issue resolution and corrective action processes when compliance gaps are identified.
  • Produce operational reporting for health system and infusion provider leadership on program performance.
  • Maintain and update program policies and SOPs as regulatory guidance and operational needs evolve.
• Lead ongoing program governance across all partner entities, establishing structured forums to monitor performance, compliance, and strategic alignment including but not limited to:
  • Facilitate joint monthly performance reviews covering financial, clinical, and compliance metrics, and driving action plans where needed.
  • Lead New Medication Review Board meetings (biweekly) and Covered Entity compliance audit reviews (quarterly), ensuring appropriate oversight, documentation, and decision-making.
  • Oversee and coordinate Steering Committee meetings (quarterly) and Annual Program Reviews, aligning executive stakeholders on program performance, risks, and strategic priorities
• Identify and drive optimization opportunities through ongoing performance reviews, expanding program impact across financial, operational, and clinical dimensions, including but not limited to:
  • Participate in monthly performance reviews to identify optimization opportunities and expand program impact.
  • Support leakage reanalysis initiatives and network expansion efforts in collaboration with Operations and Business Development teams.
  • Oversee long-term program performance and governance, driving continuous improvement and scalability across the Coral network.

Qualifications:

To excel in this role, you should possess the following qualifications:

• Required Qualifications
  • Minimum 3-5 years of direct 340B program management experience, including covered entity operations, contract pharmacy oversight, and TPA administration.
  • Demonstrated knowledge of HRSA 340B program requirements, OPAIS registration, and Medicaid carve-in/carve-out strategies.
  • Experience with 340B TPAs (e.g., Verity Solutions, Macro Helix) and dispensing platforms (e.g., CareTend, WeInfuse).
  • Strong understanding of infusion therapy workflows, specialty drug supply chains, and payer reimbursement models.
  • Proven ability to develop SOPs, deliver staff training, and lead compliance audit programs.
  • Excellent communication and stakeholder management skills; comfortable presenting to hospital leadership and executive teams.
• Preferred Qualifications
  • Board certification or advanced training in specialty pharmacy or managed care pharmacy.
  • Experience managing multi-site 340B programs across oncology, rheumatology, GI, or neurology service lines.
  • Familiarity with EHR integration workflows and data exchange between hospital and infusion center platforms.
  • Director-level candidates: 7+ years of 340B or specialty pharmacy operations leadership; experience managing direct reports and cross-functional teams.

Education:

Bachelor's or Master's degree in Healthcare Administration, Health Informatics, Public Health, Business Administration, or a related field required. Pharmacy degree (PharmD or RPh) strongly preferred.

License Requirement:

Active pharmacist licensure in good standing preferred.

Job Benefits:

Health, Dental, Vision, Life, 401k, Paid Time Off.

Location:

Remote with limited travel to client locations, internal business meetings, and other locations as needed.