Senior Global Value & Access Director - Oncology Pipeline

SUMMARY/JOB PURPOSE:

The Senior Global Value Access (GVA) Director serves as the Global Pipeline or Therapeutic Area Lead and is accountable for management and oversight of Global Payer Evidence/Value Strategies (focus on US, and key countries in EU and Asia) for multiple molecules with multiple indications. The Senior GVA Director works cross-functionally with other internal functions (e.g., Commercial Strategy Planning, US Market Access, Marketing, Clinical Development, Biostatistics, and Medical Affairs), as appropriate, and ensures that Global Payer Evidence/Value strategies and tactics align with the clinical and commercial plans.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Evidence Generation

• Provide expert input into the design of clinical development programs and ensure evidence needs for country HTA/Payers (e.g., appropriate comparator, humanistic endpoints and economic endpoints) are considered within the global development and commercialization strategies.

• Generate and leverage real world evidence (RWE) is support of Exelixis oncology molecules/products.

• Design and execute health economic and outcomes research studies/projects in alignment with development and commercial to demonstrate the value of Exelixis oncology molecules/products. This includes the application of technical knowledge to plan, execute, and interpret research/data collection findings.

Payer Strategy/Health Technology Assessment

• Work cross-functionally to develop global value propositions.

• Design and implement Global Payer Evidence/HTA/Value strategies.

• Develop and maintain in-depth knowledge of global Payer/HTA/Market Access dynamics, trends, and implications.

• Define, adapt, maintain, and utilize internal qualitative Payer Evidence/HTA requirements assessment tools.

• Lead the development of deliverables to support global pricing, reimbursement, and access (e.g., global value dossiers, components of AMCP dossiers, population models, cost-effectiveness models, and local payer dossiers)

• Build and maintain relationships with external Global Payer/HTA experts.

• Lead global payer research activities.

Other Duties and Responsibilities

• Lead the development of appropriate data dissemination plans and communicate evidence generated via publications and conference publications in collaboration with Medical Communications/Publications and other internal partners.

• Demonstrate a solid understanding of molecules/products in development, the global competitive and payer landscapes, and advances in HTA/Payer assessments.

• Assist in global business planning and forecasting exercises.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Doctorate degree in health services research, public health, epidemiology, or health economics or Clinical Degree (MD, PharmD, etc.) and a minimum of 12 years of related experience; or,

• Master's degree in health services research, public health, epidemiology, or health economics and a minimum of 13 years of related experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Fellowship in related discipline.

• Minimum 10 years of experience in Value Strategy, Health Economics/Outcomes Research, HTA/Payer Strategy, Global Market Access/Pricing following completion of doctorate degree (additional years of work experience required if candidate possesses Master's degree), the majority of which are as a member of a pharmaceutical or biotech company, preferably in oncology.

• Demonstrated track record of research projects that have resulted in development of RWE leading to publications with outcomes of strategic commercial value with payer audiences.

• Expertise in the technical and methodological aspects of non-interventional study design and in data analysis and interpretation of data. Experience conducting research regarding health economics issues, retrospective and prospective data analyses, and epidemiological research.

• Experience in conducting Global Payer/Pricing Research is required.

• Experience in conducting indirect treatment comparisons (e.g., network meta-analysis, match adjusted indirect comparisons, etc.) is preferred.

• Experience in preparing dossiers (e.g., AMCP dossier, Global Value Dossier) and models (e.g., population, budget impact, cost-effectiveness analysis) is required.

• Experience in preparing for HTA assessments outside the US (e.g., ICER, NICE, PBAC, etc.) is preferred.

Knowledge/Skills:

• Knowledge of local pricing and reimbursement requirements for major markets (e.g., US, EU5, Canada, Australia, Japan)

• Solid understanding of how to appropriately leverage evidence, including clinical trial data, RWE, comparative effectiveness data, etc. for payers, health policies, health systems, and clinical decision-making.

• Knowledge of requirements for needed health economic data to satisfy various regulatory standards in geographies outside of the United States. The ability to assess and leverage such data for use and value.

• Strong project management abilities (contracting, budgeting, vendor management) essential. Demonstrated ability to manage multiple projects including budget.

• Demonstrated ability to work collaboratively and influence within a matrix environment leading teams/personnel without direct reporting responsibility. Experience partnering with Commercial Strategy & Planning, Marketing, Market Access, Medical Affairs, Pricing, Medical Communications/Publications, Clinical Development, Regulatory, Legal, Compliance and other departments.

• Strong ability to explain technical concepts to non-experts.

• Self-starter who can work independently and deal with complex issues related to internal and external stakeholders, with minimal supervision. Strong leadership, strategic thinking, problem solving and decision-making skills.

• Excellent written, verbal, and presentation skills.

JOB COMPLEXITY:

• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.

• Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.

• Creates formal networks involving coordination among groups.

WORKING CONDITIONS:

• Ability to travel domestically and internationally estimated at 25%.

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