Head of Clinical and Medical Affairs

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Saluda Medical

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Saluda Medical is a pioneering company in the field of neuromodulation, focused on developing innovative platforms to treat chronic neurological conditions. They have created the Evoke® System, powered by their proprietary SmartLoop™ technology, which is designed to measure patients' unique biomarkers and continuously adjust stimulation to maintain therapeutic consistency. Saluda Medical is leading the way in transforming patient care through groundbreaking research and development, and their systems are widely recognized for their advanced capabilities in spinal cord stimulation therapy.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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