Director, Medical Affairs & Policy | Aus

Job description

WHAT WE’RE ABOUT At Harrison.ai http://Harrison.ai, we’re redefining what’s possible in healthcare. Through our diagnostic AI solutions, we’re building tools that support clinicians to deliver earlier, more accurate diagnoses and raise the standard of care for millions of patients worldwide. Our mission is bold but simple: to scale global healthcare capacity and create a fairer, healthier world. By using AI as a co-pilot for clinicians, we’re tackling one of healthcare’s biggest challenges, the shortage of human expertise, and giving every patient the chance to access timely, high-quality care, no matter where they live. Because while we’re building cutting-edge AI, what we’re really building is hope—that everyone can access the healthcare they deserve. And we’re just getting started. ABOUT YOUR ROLE The Director, Medical Affairs and Policy leads the integrated strategy and execution of post‑market clinical evidence generation, medical affairs, and government affairs for Harrison.ai http://Harrison.ai’s SaMD and AI‑enabled medical imaging products. The role is accountable for post‑approval clinical evidence strategy, KOL and site engagement, scientific communications, claims and promotional review, grants and sponsorship governance, and health policy and reimbursement advocacy in key global markets. The Director will partner closely with cross‑functional teams and external stakeholders to ensure that robust clinical evidence, responsible AI practice, and favourable policy environments support product adoption, reimbursement, and long‑term commercial success. Operating within a flat squad structure, the Director is an individual contributor who leads through expertise and cross-functional influence rather than direct management. WHAT YOU'LL DO: Medical affairs - 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. Government affairs & Policy - 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 http://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 http://Harrison.ai in policy‑related forums, industry groups, media engagements (as appropriate), and government‑related events domestically and internationally. WHAT YOU'LL BRING: Required: - 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. Nice to have skills and characteristics: - 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. WHY JOIN US? 🌍 Innovate for Global Good. Join us to pioneer world-first AI technology that transforms patient outcomes and helps build a healthier, fairer world. 🤝 Collaboration Across Continents. Work with brilliant minds from every corner of the globe in a culture built on trust, autonomy, and genuine teamwork. 🚀 Well-Funded & Global. Backed by world-class investors including Aware Super, Blackbird Ventures, Skip Capital, and Horizons Ventures, we’ve raised over US$240M to accelerate our global impact. 🌱 Scale Your Potential. Tap into yearly L&D budgets, mentoring, hackathons, and secondments—all supported by a transparent growth framework to grow your career. 💻Flex for Life. Work when and where you do your best—with WFH options, flexible hours, and the autonomy to make an impact your way. 🙌 Support for Every Family Journey. From fertility to parenthood, loss, and even grandparenthood—we provide inclusive, thoughtful policies to support families in every stage. WHAT'S NEXT? If you’re inspired by what we're up to, please apply now and we'll be in touch soon. We are proud to be an Equal Opportunity Employer. Diversity’s not a buzzword here, it’s in our DNA. Diverse perspectives shape our culture and make our work better. We’re committed to building inclusive teams that represent a variety of backgrounds and skills. We look forward to hearing from you.