Role Description
We are looking for a senior Medical Advisor / MSL Director to serve as the scientific and clinical backbone of one of our flagship AI-based SaMD product lines in the breast cancer space. This is a lifecycle role - spanning evidence generation, KOL engagement, clinical deployment, and regulatory support - with a dual geographic footprint: a US base with hands-on responsibility for EU-facing activities and a supporting remit for US-based medical insights related to a complementary solution and portfolio.
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Product Lifecycle - Medical Leadership
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Own the end-to-end medical strategy for the assigned breast cancer AI-based prognostic solution, from evidence generation through clinical adoption.
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Drive the scientific narrative: translate clinical data into compelling, rigorous medical communications for internal and external audiences.
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Monitor competitive landscape and clinical guidelines in early breast cancer; identify and communicate implications for product positioning.
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Contribute to claims development, and regulatory submissions in partnership with RAQA and Product and Clinical affairs.
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Clinical Evidence Generation
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Co-develop and review study protocols, statistical analysis plans, and clinical study reports for prospective and retrospective validation studies.
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Contribute medical perspective to abstract and manuscript preparation; coordinate author relationships and publication planning.
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Interface with internal teams and external partners to ensure medical accuracy of analytical outputs.
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KOL Engagement & Scientific Exchange
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Build and maintain high-value relationships with breast oncologists, pathologists, and surgeons across North America and Europe.
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Serve as the scientific face of Waiv at key congresses and symposia; deliver medical education and facilitate advisory boards.
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Identify clinical champions and research collaborators; co-develop investigator-initiated research frameworks.
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Gather and synthesize field-based medical insights; systematically feed clinical intelligence back into Product, Portfolio and R&D strategy.
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Support HTA-adjacent discussions and country-level evidence requirements in collaboration with Market Access.
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US Medical Insights β Secondary Product
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Cover US-based medical insights and KOL engagement activities for a complementary AI-based breast cancer prescreening tool.
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Identify US-specific clinical practice patterns, unmet needs, and evidence gaps relevant to prescreening and genetic testing workflows.
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Relay field intelligence to the core Medical Affairs and Product team for integration into strategy and evidence planning.
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Cross-functional Collaboration
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Collaborate closely with: Medical Affairs team, Commercial team, VP Pathology, Market Access, and R&D/Biostatistics, Marketing.
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Contribute to board-level and investor-facing scientific communications as required.
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Support Medical Affairs team capacity and knowledge-sharing on breast cancer science and medical device regulatory context.
Company Description