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RERevolution Medicines

Executive Director, HTA Strategy, Europe(m/w/x)

Basel
VollzeitVor OrtSenior

Leading EU Joint Clinical Assessments and Scientific Consultations for oncology therapies. 15+ years HTA leadership experience required. Focus on EMA alignment and early HTA feedback integration.

Anforderungen

  • Bachelor's degree required; advanced degree preferred
  • 15+ years Market Access, HTA, or evidence leadership experience
  • Leadership of EU multi-country HTA submissions in oncology
  • Familiarity with EU HTA technical assessment processes
  • Strong understanding of EU HTA Regulation, JCA processes, EMA alignment
  • Lead complex, time-critical programs across HEOR, Biostatistics, Clinical, Regulatory, Global Access
  • Executive presence in global, matrixed organizations
  • Direct experience with EUnetHTA21 pilots, early scientific advice, EMA-HTA consultations
  • Pre-commercial biotech experience; build processes and governance
  • Degree or certification in health economics or economic evaluation

Aufgaben

  • Lead EU Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC) for oncology portfolio
  • Ensure high-quality, on-time JCA submissions
  • Establish and lead JCA governance, including cross-functional teams and escalation pathways
  • Integrate EMA and JCA timelines for dossier readiness
  • Collect early HTA feedback on clinical trial design and evidence generation
  • Coordinate JCA scoping and PICO projection with Member State input
  • Translate PICO requirements into evidence and dossier execution plans
  • Deliver comparative clinical effectiveness and safety evidence
  • Conduct subgroup, sensitivity, and maturity analyses as needed
  • Ensure JCA-relevant analyses are prioritized and delivered on time
  • Interpret analytical outputs for consistency and HTA-appropriate framing
  • Respond to HTA assessor questions and requests for clarification
  • Collaborate with global and regional teams on JCA strategy and projects
  • Manage end-to-end JCA dossier, including content orchestration and quality control
  • Lead interactions for completeness checks and factual accuracy reviews
  • Support scientific advice interactions with EU HTA bodies
  • Build relationships with assessor and co-assessor Member State HTA agencies
  • Manage external partners and vendors for JCA dossier development
  • Translate JCA outcomes into country-ready materials
  • Coordinate with European operating countries for local add-ons
  • Provide strategic oversight for NICE submissions
  • Ensure alignment of evidence and positioning with JCA outcomes
  • Partner with Global Market Access and Global Evidence teams
  • Inform evidence generation strategy by anticipating JCA requirements
  • Contribute to portfolio-level access sequencing decisions
  • Represent European HTA implications in global governance forums

Berufserfahrung

  • 15 Jahre

Ausbildung

  • Bachelor-AbschlussODER
  • Master-Abschluss

Sprachen

  • Englischverhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Revolution Medicines erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

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