Medical Director – North America
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Job Description
Medical Director shaping MADx’s North American allergy diagnostics strategy. Leading clinical studies, regulatory support, reimbursement strategy and medical partnerships.
Responsibilities:
- 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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