Summary
As part of International HEOR & PCO in International Value & Access, the Patient Centered Outcomes (PCO) HTA, TA Director within the HEOR TA teams, in partnership with HEOR leads co-leads the PCO reimbursement strategy that enables measurements of patient centered outcomes to support robust payer value propositions and evidence for HTAs, optimizing international access for prioritized Novartis assets.
The PCO HTA TA Director will oversee one therapeutic area (e.g., CRM, immunology, oncology, or neurosciences) and their responsibility will span multiple assets/indications. Support and guidance to other members of the HEOR TA team for input or development of plans e.g. Health Technology Assessment Strategy Plans, Integrated Evidence Plans.
The PCO HTA TA Director will be leading the HEOR Patient Centered Outcomes strategy within a Therapeutic Area and will contribute to the OnePCO Strategy through direct interface with the Clinical Development PCO Center of Excellence (PCO COE) when novel or disease-specific PCOs are required.
In collaboration with regions and countries, The PCO HTA TA Director ensures that local PCO requirements are integrated into the PCO reimbursement strategy, and in the global and international evidence plans and PCO activities. Focus will be given to providing clear strategic rationale for and selection of health utility and other PROs for differentiation and translation to economic impact in partnership with HEOR. In addition, support the implementation of country-specific PCO evidence generation as needed to support access.
The Director, HEOR PCO, will serve as an internal expert on health utility assessment activities. She/he will also lead health state valuation projects via development and management of Time Trade-Off (TTO) or Standard Gamble (SG) studies where appropriate.
The PCO HTA TA Director will support HEOR TA on early scientific advice with HTAs e.g. EU HTA JSC and attend HTA meetings and/or support negotiations in collaboration with cross-functional and country team members. The Director will cultivate a strong partnership with team members from internal groups incl. Access, Clinical Development, PCO COE, AQS Biostat, Medical Affairs, and the International Commercial organization.
In addition, PCO HTA TA Director will represent Novartis externally and ensure thought leadership in collaboration with external partners (e.g. industry consortiums e.g., ISPOR, ISOQOL, PRO/Utility experts). Internally, the Director ensures within HEOR TA and Novartis to drive understanding of HTA requirements for PCO, health utility assessment, and adoption of standards and best practices.
About The Role
Key Responsibilities:
- Co-leads with the HEOR TA lead the development, delivery and communication of a compelling PCO reimbursement strategy within the HTAP (Health Technology Assessment Strategy Plan), IPAS (Integrated Product Access Strategy), 1BP (One Brand Plan) and aligned with Integrated Evidence Plan (IEP).
- In partnership with the PCO COE, Global Program Teams, HEOR Leads, HTA Evidence Synthesis, Access, Medical Affairs, and AQS Biostat, ensures that the PCO measurement strategy includes patient reported outcomes and health utilities of relevance for international HTAs and payers into clinical development program.
- Participates in and co-leads projects on behalf of the OnePCO Alignment Forum to ensure PCOs critical for HTAs and payers are included in in clinical trials, non-interventional studies and real-world studies for select assets and coordinates with countries to ensure alignment on local HTA and payer needs.
- Drive understanding of HTA requirements for PCO, health utility assessment, and adoption of standards and best practices by key markets.
- Leads health state valuation projects via development and management of Time Trade-Off (TTO) or Standard Gamble (SG) studies where appropriate.
- Assists in scientific discussions with HTA agencies, particularly scientific advice from e.g. EU HTA JSC, NICE, CADTH…for PRO/PCO endpoints, MCIDs, and by preparing appropriate briefing documents and dossier by ensuring robust patient value proposition is included.
- Develops strategic scientific communication plan incl. submission and presentation of research in peer-reviewed journals and scientific/methodological congresses.
- Engages with external thought leaders, identify research collaboration/partnerships and represent Novartis with external stakeholders (academic institutions, HTA agencies…) to monitor and shape the external environment with respect to patient centred outcomes research and evolving evidentiary standards for utility endpoints and ensures awareness of these changes for Novartis.
- Lead above-brand research projects/initiatives to pilot innovative methodologies for value demonstration and elevate internal standards/best practices within International Value and Access and at Novartis with cross-functional partners.
Essential Requirements
- 8+ years of Pharma Industry experience with 5+ years of experience in HEOR roles in pharmaceutical companies or consulting, with at least 3 years demonstrating specific leadership of health utility projects
- Advanced Degree in relevant field
- Experience in evaluating, developing and validating PRO/PCO instruments to meet HTA reimbursement requirements
- In-depth understanding of key patient centered outcomes measurement systems – e.g., EuroQoL, Quality Metric Short-Form measures, HUI etc.
- Ability to lead in a cross functional environment
- Ability to manage multiple priorities in rapidly changing environment
- Ability to work collaboratively to leverage other HEOR capabilities (strategy, regions, countries, COE PCO)
Desirable Requirements
- Ph.D., M.D., MBA, MSc or equivalent. Strong external interfaces and network: KOLs, clinical research & scientific groups, payers, and policy organizations
- Experience in conducting and evaluating PCO measures from conceptualization through negotiation with international health authorities. Experience in HTA submissions
Location: This role can be based in the UK, London but also in Dublin, Ireland.
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