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Sydney
2 weeks ago
Director, Medical & Government Affairs | Aus logo

Director, Medical & Government Affairs | Aus

Harrison.ai

Sydney
2 weeks ago
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Director, Medical & Government Affairs | Aus

Harrison.ai seeks a Director of Medical & Government Affairs to lead post-market clinical evidence, medical affairs, and government relations for AI-enabled medical imaging products. The role requires an advanced degree, experience in clinical program management, and knowledge of AI in healthcare. This is a remote, full-time position based in Sydney, Australia.

AI-enabledRemoteFull-timeDirectorClinical Program ManagementClinical Development Strategy

Director, Medical & Government Affairs | Aus

Harrison.ai seeks a Director of Medical & Government Affairs to lead post-market clinical evidence, medical affairs, and government relations for AI-enabled medical imaging products. The role requires an advanced degree, experience in clinical program management, and knowledge of AI in healthcare. This is a remote, full-time position based in Sydney, Australia.

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AI-enabledRemoteFull-timeDirectorClinical Program Management

Salary

Not specified

Work Location

Sydney, New South Wales, Australia, AU

Work Model

Remote

Employment Type

Full-time

Experience Level

Director

Core Qualifications

Technical (Must-have)
Clinical Program ManagementClinical Development StrategyStudy DesignTrial ManagementMedical Device IndustryPharmaceutical IndustryArtificial IntelligenceSaMDMedical ImagingRegulatory BodiesFDATGAEUGood Machine Learning PracticeICH GCPISO 14155Data Privacy Laws
Soft Skills
LeadershipInfluenceCollaborationStrategic ThinkingCommunication

Preferred Qualifications

Technical (Nice-to-have)
PhDPost-graduate QualificationDiagnostic Accuracy MetricsValidation of SaMD

Key Responsibilities

  • •Lead strategic development and delivery of a global post-market clinical evidence roadmap across the SaMD portfolio.
  • •Oversee design, conduct, reporting, and risk management of post-approval and real-world evidence studies.
  • •Provide leadership for KOL and site engagement, including identification, onboarding, and ongoing relationship management.
  • •Ensure high-quality dissemination of evidence through peer-reviewed publications, conference abstracts, scientific presentations, white papers, and other medical education activities.
  • •Lead or oversee medical review and approval of product claims, promotional and educational materials, and customer-facing content.
  • •Govern and oversee grants, sponsorships, and independent research support.
  • •Act as a senior clinical and scientific resource for internal stakeholders.
  • •Champion Good Clinical Practice, Good Machine Learning Practice, and data privacy principles.
  • •Develop and implement integrated government relations strategies supporting regulatory clearance, public reimbursement, and market access.
  • •Lead advocacy initiatives with policymakers, payers, and healthcare agencies.
  • •Build and maintain influential relationships with government officials, health technology assessment bodies, industry associations, and key policy stakeholders.
  • •Monitor, analyse, and report on legislative and reimbursement developments affecting AI in healthcare.
  • •Oversee development of position statements, policy briefs, consultation responses, and related materials.
  • •Lead and coordinate activities of external consultants, lobbyists, and public affairs agencies.
  • •Represent Harrison.ai in policy-related forums, industry groups, media engagements, and government-related events.
DirectorMedical AffairsGovernment AffairsAIHealthcareSaMDMedical ImagingClinical EvidencePolicyRemote
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