Medical Director – North America

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🔥 2 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

💵 $107k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 14%

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MADx – Macro Array Diagnostics GmbH

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

🏥 Healthcare

🍽️ Food & Beverage

🏭 Manufacturing

Healthcare • Food & Beverage • Manufacturing

MADx – Macro Array Diagnostics GmbH is an Austrian medtech company that develops and commercializes molecular immunodiagnostic tests, laboratory analyzers and cloud-based analysis software for allergy (IgE) and food-intolerance (IgG) diagnostics. The company offers multiplex ELISA-based test kits (ALEX, FOX), benchtop and high-throughput instruments (ImageXplorer, MAX 45k) and real-time cloud analytics (RAVEN/RAPTOR), emphasizing molecular specificity, big-data connectivity and regulatory compliance (IVDR, ISO 13485). MADx serves laboratories, clinics, doctors and distributors worldwide, positioning itself as a leader in molecular allergy diagnostics.

📋 Description

• Develop and execute MADx’s medical and clinical strategy for the US and Canada, with senior Director-level ownership, clear priorities and deliverables • Initiate, oversee, evaluate and publish clinical/performance studies • Drive scientific and clinical initiatives from concept through execution and follow-up • Build peer-to-peer relationships with allergists, immunologists, laboratory directors, pathologists and clinical biochemists • Establish clinical partnerships and key opinion leader collaborations for joint studies and research • Develop and drive healthcare reimbursement and market access strategies for the US and Canada • Support FDA and Health Canada activities, clinical evaluations and clinical requirements throughout the product lifecycle • Collaborate with Regulatory Affairs, Quality Management, R&D and Product Management • Assess clinical evidence adequacy and escalate gaps or potential patient-safety risks • Represent MADx at scientific conferences and contribute to international committees such as CLSI • Assess and approve clinical and medical content, including clinical and performance evaluation reports • Act as key medical contact for physicians, clinics and laboratories • Coordinate medical topics across the organization • Provide clinical and medical support and training for external clinicians

🎯 Requirements

• Medical degree (MD) with strong clinical expertise in allergy, immunology or a closely related field • In-depth understanding of allergy diagnostics and clinical practice • Established professional network in the US and/or Canada, ideally including allergists, immunologists, clinical institutions, laboratories, laboratory directors, pathologists, scientific societies and key opinion leaders • Experience in clinical or performance evaluation • Proven experience planning, conducting, evaluating and publishing clinical/performance studies • Sound knowledge of relevant regulatory requirements and standards applicable to IVDs and clinical studies, particularly FDA requirements, the US regulatory framework, Health Canada and relevant Canadian provincial requirements • Ability to critically assess clinical evidence and make well-founded medical decisions • Proactive, self-driven and collaborative, with a strategic, hands-on approach, strong ownership and ability to independently turn scientific opportunities into concrete initiatives and measurable outcomes • Strong networking, stakeholder-management, communication and presentation skills when working with medical professionals and cross-functional stakeholders • Experience in project planning and project controlling; comfortable working in a dynamic, growing international organization • Fluent in English; French is a plus • 10+ years of experience in allergy, immunology or the diagnostics industry is a strong advantage, ideally including molecular allergy diagnostics or multiplex technologies

🏖️ Benefits

• Permanent full-time position • Flexible working hours • Remote or hybrid working model in the US or Canada • Opportunity to shape MADx’s medical and clinical strategy in North America • Space to bring ideas to life and drive scientific and clinical initiatives • Growing international environment grounded in sustainability, equity, diversity, inclusion and mutual respect

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