The Sr. Director, Global HEOR will be responsible for development and execution of value evidence plans to support health technology assessment and market access goals within key markets outside the US. This role will partner with global, regional, and local market access, regulatory, medical affairs, and commercial teams to develop, execute, and communicate on the clinical and economic evidence requirements to ensure the local country access teams have a robust value evidence portfolio to gain timely reimbursement within public and private payers.

Primary Responsibilities

• Develop value evidence generation plan for key markets globally
• Ensure delivery of HEOR materials to support Health Technology Assessment (HTA) submissions including the Global Value Dossier (GVD) and economic models
• Maintain strong working relationships with local and regional market access, medical and commercial teams
• Engage with vendors and external experts to validate HEOR strategy and technical approach
• Responsible for the design and management of health outcomes studies including: systematic literature reviews, retrospective database analyses, prospective physician or patient studies, and country specific cost effectiveness and budget impact models
• Responsible for developing HEOR publication plans for key markets in collaboration with appropriate cross functional partners
• Collaborate cross functionally on developing and implementing the payer value generation strategies for products in development

Education/Experience/Skills

• Master's degree in public health, economics, epidemiology, health services research, pharmacy, medicine, or HEOR-related field; strongly preferred Doctorate degree
• Targeting 7 years' experience respectively in global biopharmaceutical or medical device industry
• Requires experience with designing economic studies including the development of economic models
• Requires experience in outcomes research methodologies (retrospective observational cohort, cross-sectional studies, registries, etc.) to support product development and reimbursement efforts is required
• Rare disease 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
• Ability to support multiple projects while being well-organized, have strong time management skills, and attention to detail
• Ability to accommodate shifting priorities, demands and timelines
• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team's ability to achieve goals and meet timelines/deliverables
• Knowledge of regulatory guidance documents and scientific guidelines (FDA and EMA guidance resources; HTA requirements, etc.)
• Travel (up to 40%) for conferences, meetings, and HEOR project or team-management related business

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel by car or airplane independently overnight up to 40% of the time and work after hours if required by travel schedule or business issues. International travel may be required.