Head of Clinical and Medical Affairs

🕒 Agosto 5

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Saluda Medical

Saluda Medical

201 - 500 funcionários

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A Saluda Medical é uma empresa pioneira no campo da neuromodulação, focada no desenvolvimento de plataformas inovadoras para tratar condições neurológicas crônicas. Eles criaram o Evoke® System, alimentado por sua tecnologia proprietária SmartLoop™, projetada para medir biomarcadores únicos dos pacientes e ajustar continuamente a estimulação para manter a consistência terapêutica. A Saluda Medical está liderando o caminho na transformação do cuidado ao paciente por meio de pesquisa e desenvolvimento inovadores, e seus sistemas são amplamente reconhecidos por suas capacidades avançadas em terapia de estimulação da medula espinhal.

Descrição

• Establish and direct the clinical and medical affairs functions globally • Oversee all medical and clinical activities across the organization • Lead clinical research and evidence strategy and collaborate on evidence generation and communications plans • Partner with Regulatory Affairs, Commercial, and R&D teams to align medical, clinical, product portfolio, and business objectives • Communicate the scientific foundations of and evidence associated with the Saluda system • Develop and maintain key thought leader and society relationships • Oversee investigator-initiated research and studies • Oversee conference presence through abstracts, posters, and presentations • Lead publication planning and dissemination of scientific data • Own the clinical quality system, clinical regulatory requirements, data integrity/quality, and clinical operations • Oversee customer requests for Medical Information in accordance with applicable regulations • Build, lead, and develop the Clinical and Medical Affairs team • Foster an environment of integrity, professionalism, accountability, and mutual respect

🎯 Requisitos

• 15+ years of direct clinical and/or medical affairs experience in medical devices • Experience with active implantable medical devices • Minimum of a Master's degree in science, biomedical, or health-related field • PhD preferred • Experience with the neurostimulation industry preferred • Active implantable experience in the neuromodulation field preferred • Demonstrated success working with FDA and/or other regulatory and governmental agencies • Demonstrated success developing clinical evidence strategies and designing and conducting clinical trials for medical devices and/or pharmaceuticals • Knowledge of neuroscience and/or biomedical science • Excellent verbal and written communication • Demonstrated leadership experience, including strategic, analytical, planning, and communication skills • Excellent organizational and project management skills with attention to detail • High degree of personal integrity • Ability to work effectively across time zones and cultures • Ability to travel domestically (20% of time) and internationally

🏖️ Benefícios

• Ability to work effectively across time zones and cultures • Ability to travel domestically (20% of time) and internationally • Diversity and equal opportunity commitment

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