Associate Director, Government Pricing and Contracting - United States
POSITION OBJECTIVES: POSITION ACCOUNTABILITIES:
- Provide senior leadership with strategic advice and business impact assessment and detailed understanding of Government Pricing as it pertains to current and future legislative changes governing the Government pricing programs outlined above.
- Consult regularly with outside experts to monitor policy trends and regulation changes, in order to develop strategic recommendations for Government Pricing updates and communicate implications to broader Commercial team and senior leadership; responsible for providing accurate assessments relevant to Takeda Oncology specifically from a multitude of sources.
- Stay informed about any new government guidance; collaborate with Legal to ensure appropriate implementation of guidance and present business impact analysis to senior management.
- Perform US and global pricing research and analysis on special projects, including pipeline products and potential in-licensing candidates
- Perform research and analysis for US Market Access as needed that may stretch above and beyond Government Pricing.
- Lead and perform the development and implementation of methodologies, policies and practices necessary to ensure compliance with the requirements of federal and state healthcare programs. Work with OBU Legal Counsel and industry experts to validate Pricing methodologies to appropriately manage financial risk. Validate (and perform where necessary) calculations to ensure consistency with methodology and to verify accuracy. Ensure timely submission of required pricing reporting as follows:
- Average Manufacturer Price (AMP), Best Price (BP) and Average Selling Price (ASP) submission to the Center for Medicare and Medicaid Services (CMS)
- Calculation and submission of the federally mandated pricing to MillenniumDirect/NINLARODirect/Wholesalers for the 340B/Public Health Service
- Federally mandated pricing submission to the Veterans Administration including Non-Federal AMP (Non-FAMP), Federal Ceiling Price (FCP) and Federal Supply Schedule Pricing (FSS).
- Oversee the preparation and presentation of quarterly Government Pricing reviews with CFO/SVP, Finance, Legal, and other key stakeholders.
- Responsible for accurately and timely forecasting gross to net and assumptions based on analysis of historical trends and impact of government policies for all Takeda Oncology specialty products and inform USMA leadership of all components in preparation for leadership meetings and planning. Collaborate with finance to manage accruals and validate actuals on a monthly basis.
- Model price increase scenarios and present recommendations to management based on Takeda Oncology pricing strategy, current pricing, and current or upcoming government programs legislation
- Lead price change communication to internal and external stakeholders (pricing compendia, wholesalers, etc)
- Design and develop pricing guides and models to be utilized by the Market Access team in support of the organization access strategy.
- Manage FSS contract including overseeing renewals and modifications.
- Lead integration efforts related to merger or acquisition stakeholders as it relates to Government Pricing, GPO contract development and implementation, and Gross to Net forecast as well as any future acquisitions or addition of products at Takeda Oncology. Responsible for ensuring leadership stays abreast of all integration and implementation work by GP team
- Understand any other new partner GP methodology; evaluate and implement changes as necessary to align with Takeda practices.
- Develop AMP calculation methodology and gain legal approval for the new specialty product to be launched:
- Design and implement a transition plan for any outsourced approach, methodology and tools to Takeda internal practices
- Design and implement a plan to transition any external government pricing calculations for currently marketed product(s) into Takeda’s processes and systems.
- Develop and build Gross to Net forecast for any newly acquired products
- Business owner of the ModelN system:
- Lead implementation of pricing model in ModelN in accordance to company policies and government requirements for Government Pricing.
- Manage Pricing System to ensure all policies and procedures are accurately reflected in the system. Analyze sales and discount data to ensure accurate classifications and discounts are flowing into the government pricing calculation
- Design GPO contracts in ModelN to accurately reflect the commercial contract terms for all Takeda Oncology products to ensure accurate payments of discounts/rebates.
- Define reporting requirements and ensure system is accurately set-up to deliver necessary business reports.
- Lead any required upgrades, service patches or updates to the ModelN system including addition of any new products or NDCs.
- Create custom ModelN training documentation for adherence to Millennium SOPs. Liaise with internal and external IT support to ensure accurate and timely data loads
- Define requirements for IT to maintain the monthly chargeback audit.
- Oversee MDM (ARES) operations as it pertains to Government Pricing, Medicaid, and Contracting.
- Oversee Medicaid rebate process including the management, development and training of junior team members/contractors.
- Direct commercial contracting operations. Responsible for ensuring payments for administrative fees and rebates are made accurately and timely as well as providing follow-up support to internal stakeholders for GPO inquiries related to contract performance.
- Manage external vendor providing Medicare Part D Coverage Gap operational services and manage and perform operational services if determined to come in-house. Oversee and perform validation, payment and potential dispute of received invoices.
- Lead audit response team during external and internal audits events. Provide policies and processes overview to the audit team; ensure timely response to auditor’s inquiries by also providing the requested supporting data and documentation.
- Responsible for the appropriate and efficient resource allocation to fulfill the growing demands in the area of Government Pricing due to the expansion of the Takeda oncology portfolio and the evolving commercial contracting strategy. Responsible for recruiting, hiring and training of FTEs as well as contractors and/or consultants to supplement internal capabilities as approved. Demonstrate strong focus on FTE development and performance management.
- Responsible for appropriate document retention and keeping current with updates including policies, SOPs, workflows and training. Other duties as assigned.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs