Director, US Policy and Advocacy

Role Summary

The Director, US Policy and Advocacy provides analysis and direction to facilitate strategy development, policy development, trade association engagement, coalition building with aligned stakeholders, and strategy execution. The individual is an integral member of the commercial team that is responsible for leading and developing comprehensive advocacy strategies that shape the public policy environment for existing and pipeline cell therapies for Iovance. This role requires extensive US healthcare reimbursement policy experiences, strong critical thinking skills, a solution-oriented mindset, and ideally cell/gene therapy experience. This position reports to the Head of Policy, Pricing and Distribution.

Responsibilities

• Monitors healthcare legislative trends, understands healthcare policies, assesses implications of policies, and develops strategies that address barriers to provider and patient access.
• Leads communications on commercial goals and priorities in cell therapy and ensures policy strategies are aligned with these Key areas of support include issue identification; political insights on risks and opportunities; strategy and policy development; advocacy to Federal, State, Local and Administration policymakers; and, building advocacy and coalitions to shape public policy.
• Understands total cost of care and all aspects of Medicare and Commercial reimbursement (coding, coverage, and payment) for inpatient and outpatient settings across payer segments.
• Supports development of proactive, comprehensive policy advocacy strategies that include position and message development, coalition building, securing third-party engagement and commentary, direct and indirect advocacy, and creating and disseminating advocacy materials and tools. Coordinate with cross-functional colleagues in the development and execution of these strategies.
• Continually assesses Federal and State policies to assure that any impact to Iovance is understood and communicated to appropriate stakeholders at Iovance. Proactively address Iovance views with the appropriate policymakers and/or trade organizations.
• Monitor for new Federal and State policy releases (rules and regulations), quickly review for impact to Iovance and our products, and draft comment letters as necessary to engage in the rulemaking process.
• Monitor and understand the impact of government price reporting requirements and policies on Iovance products and to inform Iovance business decisions.
• Actively participate in industry trade organization committee meetings to advocate for Iovance positions and inform relevant internal stakeholders of trade activity and priorities.
• Collaborates with Market Access team to assess potential changes to Government Payer policies with a focus on Medicare and Working with team to develop contingency plans for policy impact(s).
• Stays in close communication with the executive team to proactively discuss policies that may impact Iovance; always being prepared with possible next steps and solutions.
• Partners with the Commercial Leadership team to proactively identify policies that may be critical to Iovance success, including Commercialization success and therapy access.
• Partners with Forecasting to incorporate policy changes into Forecasting assumptions.
• Implements and monitors systems to measure effectiveness and impact of public policy activities on the policy environment and company performance.
• Manage functional budget and external consultants.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Qualifications

• Required: BA or BS degree.
• Required: Minimum of 12+ years of experience in government affairs and policy.
• Required: Proven track record and expertise at both the State and Federal government levels.
• Required: Experience working closely with industry trade organizations such as BIO and ARM.
• Required: Collaborative and can-do approach with cross-functional colleagues, including Commercial, Advocacy, Legal, and Executive leadership.
• Required: Excellent critical and strategic thinking skills.
• Required: In-depth knowledge of current US government pricing statutes and regulations including the Inpatient Prospective Payment System, Medicaid Drug Rebate Program, Public Health Service (340B Program), Medicare Part B (Average Sales Price), Federal Supply Schedule Program, and state reporting requirements.
• Required: Demonstrated negotiation skills and ability to make sound business arguments to influence external decision makers as well as to establish Iovance’s reputation as a valued business partner.
• Preferred: Advanced degree.

Education

• BA or BS degree required; Advanced degree preferred.

Additional Requirements

• The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions.
• Must be able to remain in a stationary position for prolonged periods; may need to move about inside an office; ability to lift or carry light objects; visual acuity for reading and data analysis; repetitive hand/wrist movements; ability to communicate effectively.
• Work environment: professional or remote office; standard office equipment and keyboards.