Overview
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.
Essential Functions and 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.
Required Education, Skills, and Knowledge
- BA or BS degree is required.
- Minimum of 12+ years of experience in government affairs and policy.
- Must have experience working in biotech, pharma or the Healthcare industry.
- Proven track record and expertise at both the State and Federal government levels.
- Experience working closely with industry trade organizations such as BIO and ARM.
- Collaborative and can-do approach with cross-functional colleagues, including Commercial, Advocacy, Legal, and Executive leadership.
- Excellent critical and strategic thinking skills.
- 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.
- 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 Education, Skills, and Knowledge
- Advanced degree preferred.
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. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
#LI-Remote
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected].
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
