Director, HEOR

The Director, HEOR is responsible for developing and performing the value evidence generation and dissemination strategy for health economic and outcomes research (HEOR) including real-world evidence (RWE) and clinical outcomes assessments (COAs). This individual will oversee planning and execution for all activities involved in developing HEOR strategies and tactics to gain and maintain market access and reimbursement for Kura’s lead pipeline product.

ESSENTIAL JOB FUNCTIONS:

• Shape HEOR strategies to generate evidence of the value of Kura’s lead asset, in alignment with the brand strategic plan, and integrate within core medical plans, value & access plans, evidence generation plans, and launch excellence plans
• Establish an integrated HEOR plan aligned with Commercial, Medical, Market Access, and Scientific objectives
• Ensure HEOR strategies, plans and tactical executions are evidence based, scientifically and technically valid, and medically relevant; of clinical, humanistic, and economical importance; patient focused; address the needs of regional regulators, HTA, patients, health care providers, and policy makers and regulators
• Oversee and guide development and implementation of patient reported outcomes (PRO) and COA end points strategy
• Lead the development of value story, value dossiers, economic models, and planning for health technology assessments (HTAs) to demonstrate the value of Kura’s therapies
• Actively monitor the changing healthcare landscape to identify and integrate emerging HEOR trends
• Support preparation and coordination for HTA/payer advice, mock preparations, submissions, face to face meetings and objection handling
• Represent Kura on HEOR issues at key forums, conferences and professional associations and trade associations, including monitoring ad communicating activities by such forums to executive leadership
• Deliver distinctive ways to disseminate evidence appropriately to demonstrate compelling value propositions for population health decision-makers/payers
• Use distinctive approaches for proactive evidence dissemination in a compliant manner
• Direct and implement relevant HEOR initiatives with external entities
• Contribute to development and execution of overall and HEOR-specific publication plans
• Other duties as assigned

JOB SPECIFICATIONS:

• Master's or Doctorate degree in public health, medicine, pharmacy, economics, epidemiology, health services research or HEOR-related field
• 8+ years experience in pharmaceutical industry, with 5+ years of direct experience in HEOR (Real World Evidence, Patient Reported Outcomes, Clinical Outcomes Assessment, Health Policy, Population Health, etc.)
• Experience in outcomes research methodologies (retrospective observational cohort, cross-sectional studies, registries, etc.) to support product development and reimbursement efforts is required
• Experience with execution of scientifically robust qualitative and quantitative studies, development and validation of COA measures including assisting clinical development teams in implementing COAs in clinical trials to measure patient relevant endpoints
• Hematology/oncology experience with interactions with US and ex-US reimbursement agencies is preferred
• Understanding of the global healthcare environment, clinical research processes, global regulations, and ethical guidelines
• Highly-developed communications skills (written/verbal) and interpersonal savvy
• Ability to create, track and plan timelines and budgets
• Excellent organization and multi-tasking skills
• Ability to accommodate shifting priorities, demands and timelines
• Knowledge of regulatory guidance documents and scientific guidelines (FDA guidance; FDA qualification documentation; dossier outline; EMA guidance resources; ISPOR Task Force Documents, etc.) • Understanding of instrument development and validation process
• Strong computer skills (Microsoft Office, etc.) and knowledge of database management (Veeva Vault, etc.)
• Travel (up to 40%) for conferences, meetings, and HEOR project or team-management related business

The base range for a Director is $218,236 - $246,845 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.