Director, Government Price Reporting

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

Key Accountabilities/Core Job Responsibilities:

• Government Price Reporting Compliance & Analytics:

  • Oversee the timely and accurate calculation and submission of required government pricing metrics, including Average Manufacturer Price (AMP), Best Price (BP), 340B Ceiling Price, Non-Federal Average Manufacturer Price (NFAMP), URA, and others as applicable.

  • Forecasting & analytics including average sales price (ASP), AMP and URA

  • Ensure all government rebates & discounts are calculated accurately, reconciled and processed in a timely fashion.

  • Ensure compliance with all regulatory requirements under CMS, VA/DoD, and other relevant agencies.

  • Ensure robust documentation and SOPs for all aspects of Denali’s government price reporting operations.

  • Monitor and interpret evolving regulations to ensure adherence to current and future requirements.

• Outsourced Activities Oversight:

  • Evaluate and recommend insourced vs outsourced solutions for each aspect of Denali’s government price reporting compliance.

  • As applicable, manage relationships with outsourced vendors responsible for government pricing calculations, data management, and compliance reporting.

  • Establish performance metrics and ensure internal and vendor accountability for quality and accuracy.

• Collaboration & Cross-Functional Alignment:

  • Work closely with finance, contract operations lead, legal, market access, and commercial teams to ensure accurate data inputs and alignment on government price reporting requirements and compliance.

  • Act as the primary point of contact for internal audits and external inquiries related to government price reporting.

  • Serve as the primary liaison to external auditors for government pricing-related inquiries as required, ensuring timely and accurate responses to auditor requests regarding data, pricing methodologies, systems, and controls.

  • Facilitate data sharing between the Government Price Reporting function and the Gross-to-Net team, ensuring consistency and accuracy in key inputs.

  • Ensure all pricing adjustments, methodologies, and assumptions are documented and reconciled between the Government Price Reporting and Gross-to-Net teams.

• Process Improvement & Risk Mitigation:

  • Identify and implement process improvements to enhance the accuracy, efficiency, and compliance of government price reporting, and to ensure optimized integration between government price reporting and gross-to-net workflows.

  • Develop and maintain robust policies, procedures, and documentation to mitigate compliance risks.

• Data Analysis & Insights:

  • Conduct thorough analysis of pricing and transaction data to support accurate calculations and identify potential discrepancies.

  • Provide actionable insights and recommendations to internal stakeholders based on government pricing trends and compliance considerations.

Qualifications:

• Bachelor’s degree in finance, business, healthcare, or related field (advanced degree preferred).

• 7 years of experience in government price reporting, with a strong understanding of ASP, AMP, BP, 340B, NFAMP, URA, and related compliance requirements.

• Expertise in Medicaid Drug Rebate Program, Medicare Part B, VA/DoD pricing, and 340B program regulations.

• Experience managing outsourced government pricing activities is highly desirable.

• Strong analytical and problem-solving skills with proficiency in managing large datasets.

• Exceptional attention to detail, organization, and project management skills.

• Strong communication and collaboration abilities to work effectively across internal and external stakeholders.

Critical Success Factors

• Regulatory Expertise: Deep knowledge of government pricing programs and the ability to stay ahead of regulatory changes.

• Operational Leadership: Proven ability to manage outsourced relationships and ensure accountability for compliance activities.

• Cross-Functional Collaboration: Willingness to partner with diverse teams to align pricing compliance with broader business goals.

• Proactive and Solution-Oriented: Anticipates challenges, identifies risks, and implements innovative solutions to ensure compliance and operational efficiency.

This role offers the opportunity to be a key contributor to the success of Denali’s innovative therapies while ensuring that Denali meets the highest standards of government price reporting compliance in a complex and evolving regulatory landscape.

Salary Range: $196,000.00 to $248,000.00 .  Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
 

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary : $196,000 - $248,000