Director, Medical and Government Affairs

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harrison.ai

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🤖 Artificial Intelligence

☁️ SaaS

🤝 B2B

💰 Series B on 2021-12

Artificial Intelligence • SaaS • B2B

Harrison. ai is a medical imaging AI company that develops and deploys diagnostic artificial intelligence solutions for radiology. Its products—such as Harrison. ai Comprehensive Care—automate detection and triage for chest X‑rays and non‑contrast head CTs, surfacing critical and incidental findings rapidly within clinicians' existing workflows. The company focuses on improving clinical throughput, reducing diagnostic delays, and integrating AI into hospital and radiology provider systems across multiple countries.

📋 Description

• Lead strategic development and delivery of a global post‑market clinical evidence roadmap across the SaMD portfolio, aligned with regulatory, reimbursement, and commercial objectives. • Oversee design, conduct, reporting, and risk management of post‑approval and real‑world evidence studies, including protocol development, ethics submissions, statistical analysis plans, study reports, and performance evaluation summaries. • Provide leadership for KOL and site engagement, including identification, onboarding, and ongoing relationship management of clinical partners and investigators. • 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 to ensure clinical accuracy and compliance with relevant regulations and codes. • Govern and oversee grants, sponsorships, and independent research support in accordance with ethical, compliance, and transparency requirements. • Act as a senior clinical and scientific resource for internal stakeholders (commercial, product, regulatory, quality, technical, and data science teams), ensuring that clinical insights and customer needs inform product strategy and lifecycle management. • Champion Good Clinical Practice, Good Machine Learning Practice, and data privacy principles across evidence generation and medical affairs activities. • Provide strategic leadership across Medical Affairs, ensuring a unified, evidence‑based and compliant external engagement strategy. • Support Guild needs as required. • Develop and implement integrated government relations strategies that support regulatory clearance, public reimbursement, and market access for SaMD and AI‑enabled products in priority markets. • Lead advocacy initiatives with policymakers, payers, and healthcare agencies, translating product and evidence strategies into clear policy positions and reimbursement narratives. • 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, medical imaging, and medical devices, proactively identifying risks and opportunities for the business. • Oversee the development of position statements, policy briefs, consultation responses, and related materials that articulate Harrison.ai’s perspectives on AI, safety, bias, transparency, and clinical value. • Lead and coordinate activities of external consultants, lobbyists, and public affairs agencies, ensuring alignment with corporate priorities and maximising value from partnerships. • Represent Harrison.ai in policy‑related forums, industry groups, media engagements (as appropriate), and government‑related events domestically and internationally.

🎯 Requirements

• An advanced degree in a relevant field (e.g., Medicine, life sciences or medical science). • Experience in clinical program management, clinical development strategy and study design/trial management and reporting within the medical device or pharmaceutical industry. • Experience working in research involving artificial intelligence, SaMD and/or medical imaging. • Experience working with regulatory bodies, including an understanding of regulatory requirements in relation to clinical studies and medical device submissions (FDA, TGA, EU). • Detailed knowledge and understanding of Good Machine Learning Practice Principles, ICH GCP and/or ISO 14155 and Data Privacy Laws. • PhD and/or post-graduate qualification in a relevant area of medical science. • Demonstrated ability to influence projects through scientific and operational expertise; proven ability to interpret clinical data analysis involving diagnostic accuracy metrics. • 3+ years working in validation of SaMD involving artificial intelligence products. • 10+ years of experience in the medical device or pharmaceutical industry.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options