layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Director, Government Pricing & Contract Operations at Dyne Therapeutics

Government Pricing & Reporting
Serve as the internal expert on U.S. Government Pricing programs, including AMP, Best Price, ASP, Medicaid Drug Rebate Program, 340B, Non-FAMP, FCP, and Federal Supply Schedule pricing.
Oversee third-party vendors responsible for government pricing calculations, validations, submissions, and reporting.
Review and approve pricing methodologies, assumptions, and reporting outputs to ensure compliance and accuracy.
Assess the impact of pricing, contracting, distribution, and market access strategies on government price reporting.
Monitor and implement regulatory and policy changes, including CMS, OIG, and Inflation Reduction Act (IRA) requirements.
Maintain government pricing policies, SOPs, controls, and documentation to support compliance and audit readiness.
Lead responses to audits, compliance reviews, and governmental inquiries.
Partner with Finance to support rebate accruals, forecasting, and financial reporting requirements.
Drive process improvements, automation, and data quality initiatives to enhance operational efficiency and compliance.
Contract Operations & Administration
Provide leadership and oversight for contract operational processes, ensuring accurate implementation and administration of approved contract terms.
Ensure accurate maintenance of contract records, documentation, eligibility files, and contract management systems.
Oversee rebate administration processes, including validation, adjudication, dispute resolution, and payment activities managed through external vendors.
Partner with Legal, Market Access, and Compliance to evaluate contract structures, operational feasibility, and government pricing implications.
Drive continuous improvement initiatives to enhance operational efficiency, reporting and analytics capabilities, and performance measurement to support informed business decision-making and contracting strategies.
Maintain contract documentation, controls, and procedures to support audit readiness and continuous improvement.
Leadership & Cross-Functional Collaboration
Build strong partnerships across Market Access, Finance, Legal, Compliance, Trade, Commercial Operations, and external vendors.
Lead cross-functional initiatives related to government pricing compliance, contract operations, and process improvements.
Communicate complex pricing and contracting concepts to senior leadership and business stakeholders.
Foster a culture of compliance, accountability, collaboration, and operational excellence.
Education and Skills Requirements: Bachelor's degree in Finance, Accounting, Economics, Business Administration, Healthcare Administration, or a related field.
10+ years of experience within the pharmaceutical or biotechnology industry, including significant experience in Government Pricing and/or Contract Operations.
Deep knowledge of U.S. Government Pricing regulations and reporting requirements, including AMP, Best Price, ASP, Medicaid Rebates, 340B, Non-FAMP, FCP, and Federal Supply Schedule programs.
Demonstrated experience managing external vendors supporting government pricing calculations, reporting, and contract administration activities.
Experience overseeing rebates, chargebacks, contract administration, and market access operational processes.
Strong understanding of pharmaceutical pricing, reimbursement, distribution, and contracting dynamics.
Proven ability to interpret complex regulations and implement compliant business processes and controls.
Strong leadership, analytical, project management, and communication skills with the ability to influence cross-functional stakeholders.
Preferred
Advanced degree (MBA, MS, PharmD, JD, or equivalent).
Experience in rare disease, specialty pharmaceutical, or biotechnology organizations.
Experience supporting product launches and commercialization efforts.
Experience with Government Pricing and Contract Management systems such as Model N, Revitas, SAP, or similar platforms.
Knowledge of emerging government pricing regulations, including Inflation Reduction Act (IRA) requirements.

Director, Government Pricing & Contract Operations

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