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Europe health technology assessment associate lead

Opfikon
Job-Room
Inserat online seit: 21 Januar
Beschreibung

About the role: - Partners with regional access leads to anticipate evidence needs from HTA stakeholders across Europe, by collaborating with internal cross-functional teams to gather and synthesize evidence for EU HTA-related projects, including PICO surveys and data consolidation. - Supports the development of market access strategies and clinical development plans for Takeda’s oncology portfolio, focusing on evidence needs for Europe and Canada HTA/payer stakeholders. - Co-leads the preparation and submission of European Union Health Technology Assessment (HTA) documents, including Joint Clinical Assessments and Joint Scientific Consultations, ensuring compliance with EU Joint HTA guidelines and processes. - Promote Takeda’s values and foster collaboration with cross-functional and global/region/LOC partners to enhance awareness and adoption of EU HTA evidence requirements. How you will contribute: - Co-leads the strategy and development of high quality HTA government submission dossiers for the European Union Join Clinical Assessments (JCA) and Joint Scientific Consultations (JSC) for new oncology medicines with the EUCAN Access Lead - In partnership with global and EUCAN PVA leads, ensure timely completion of comprehensive HTA and payer evidence requirement mapping via PICO simulations for assigned assets to input into global development plans, statistical analysis plans and evidence generation plans - As a key member of the Payer Value and Patient Access (PVPA) sub-team, responsible for representing the joint EU HTA archetype’s evidence needs in internal regional and global forums including communicating requirements and changes in joint HTA guidelines to inform the global brand, PVPA functional plan and the asset clinical development plans - In collaboration with the EUCAN Access Lead: 1) Co-leads Joint Scientific Consultation to collect feedback on clinical trial considerations to inform clinical development and evidence generation strategies / 2) Co-leads the EU JCA submission teams, leveraging expertise and collaborating closely with regional, global and LOC members with the - Provide single point of contact for all JCA and JSC related evidence topics for assigned priority assets to relevant internal partners and collaborators as well as external stakeholders, interfacing with relevant sub-committees of the HTA Coordination Group. - Guides internal stakeholders for the assigned assets on the methodological requirements and specifications for the EU HTA Regulation methods and procedures to complement existing product area expertise. - Maintain up-to-date knowledge of EU HTA guidelines, methods, and processes, and communicate relevant updates to internal stakeholders. - Responsible for understanding trends, relationships/influence and collaboration of national HTA/payers, regulatory agencies (EMA) with the EU HTA CG and provide these strategic insights to global PVA. Based on these insights, shape EU joint HTA and reimbursement strategies Education, Behavioural Competencies and Skills: Required Qualifications: - Minimum bachelor’s degree, advanced / graduate degree (MSc, PhD, MPH, MPP, MBA) preferred. - Minimum of 6 years’ experience in biopharmaceuticals industry or healthcare consulting - Minimum of 4 years’ experience in market access, health economics, pricing, health policy, outcomes research and/or consulting on these topics showcasing increasing responsibility and experience in similar roles - Strong understanding of the EU payer and HTA environment, HTA trends, reimbursement guidance and technical methodologies (etc. EU HTA, NICE, TLV, G-BA, HAS.) – such as health economics and HTA reimbursement decision-making processes. - Demonstrated advanced verbal and written communication, presentation and influencing skills – proven ability to influence without authority and work effectively with cross-functional teams. - Ability to manage complex projects with multiple stakeholders and work well under pressure; previous experience managing complex projects. - Solid knowledge of drug development processes and familiarity with global pharmaceutical cross-functional teams in order to provide input into key deliverables such as CDP, EGP and SAP - Proven ability to productively navigate ambiguity, complex trade-offs and constraints in global matrix discussions, driving for optimal fit-for-purpose HTA submission deliverables - Ability to frame HTA strategies and arguments and be able to convert evidence into clear value messages for advocacy and use with stakeholders, build close partnerships with GMA/GME, GEO, GHE and R&D organizations - Hands on experience in health technology assessment tools, value materials, methods, evidence synthesis approaches and clinical and HTA/payer insight elicitation Preferred Qualifications: - Advanced / graduate degree (MSc, PhD, MPH, MPP, MBA) - Degree or diploma certificate in health economics or economic evaluations - Previous experience in Oncology - Previous experience in an above country role (regional or global) - Previous direct experience leading a national HTA submissions or early scientific advice with an HTA or regulatory agency is a plus Travel Requirements: - 20% Domestic and/or International travel required Additional Information: - Prior experience in assessing evidence needs for major HTA / payer stakeholders from EU5 and / or Canada - Excellent collaboration and communication skills with proven experience in excelling in matrix environments - Experience in internal stakeholder management and a solution mindset - Strong understanding of clinical development process

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