[Hiring] Medical Director @MacroArray Diagnostics GmbH

Role Description

We need you for:

• Developing and executing MADx’s medical and clinical strategy for the US and Canada, with senior Director-level ownership, clear priorities and deliverables, aligned with regulatory, market access and commercial objectives.
• Proactively initiating, overseeing, evaluating and publishing clinical/performance studies and independently driving scientific and clinical initiatives from concept through execution and follow-up.
• Building peer-to-peer relationships with allergists, immunologists, laboratory directors, pathologists and clinical biochemists, and establishing clinical partnerships and KOL collaborations for joint studies and research.
• Developing and driving healthcare reimbursement and market access strategies for the US and Canada that fit with current market dynamics and the competitive landscape.
• Supporting FDA and Health Canada activities, clinical evaluations and clinical requirements throughout the product lifecycle in close collaboration with Regulatory Affairs, Quality Management, R&D and Product Management.
• Assessing the adequacy of clinical evidence and escalating gaps or potential patient-safety risks.
• Representing MADx at scientific conferences and contributing to international committees such as CLSI.
• Providing expert assessment and approval of clinical and medical content, including clinical and performance evaluation reports (CER/PER).
• Acting as the key medical contact for physicians, clinics and laboratories, coordinating medical topics across the organization, and providing clinical and medical support and training for external clinicians.

Qualifications

• 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 and proven experience in 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.
• 10+ years of experience in allergy, immunology or the diagnostics industry is a strong advantage, ideally including molecular allergy diagnostics or multiplex technologies.
• Proactive, self-driven and collaborative, with a strategic, hands-on approach, strong ownership and the 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.

Requirements

• For this position, we offer a market-competitive minimum annual gross salary of 107.000 USD based on full-time employment. Final compensation will be determined based on qualifications and experience.

Benefits

• A permanent full-time position with flexible working hours and a remote or hybrid working model in the US or Canada.
• The opportunity to shape MADx’s medical and clinical strategy in North America and advance allergy diagnostics for patients.
• Space to bring your ideas to life and drive scientific and clinical initiatives, working closely with our headquarters in Austria and international colleagues.
• A growing international environment where questions and ideas are welcome, grounded in sustainability, equity, diversity, inclusion and mutual respect.

Company Description

We have revolutionized allergy diagnostics and have been operating successfully in around 115 countries for over 10 years with our diagnostic products and patented technologies. Our products help clarifying allergies in a single step. Allergies are diagnosed in a highly specific manner so that patients receive help by their specialist in no time. We increase quality of life, enable personalized treatment, advance research and relieve our health system.