Director, Clinical 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

• Formulate clinical research and evidence generation strategy • Plan, implement, manage, and report applicable clinical studies and associated regulatory activities • Collaborate with Research and Development, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality, and Operations • Enable global market access and adoption of Saluda Medical's class III implantable electrical stimulation therapy • Develop, maintain, and optimize the clinical quality system, clinical regulatory requirements, and data integrity/quality • Establish detailed program plans and drive execution toward objectives • Assess risks and implement strategies to ensure successful clinical delivery • Contribute to the strategic direction and implementation of clinical affairs objectives and processes • Direct and collaborate with internal and external staff to conduct assigned clinical programs • Develop protocols, statistical analysis plans, reports, and other clinical study documentation • Support manuscripts, abstracts, data presentations, and health economic value initiatives • Promote and embody high-performance culture and behavior expectations • Lead issue identification and resolution

🎯 Requirements

• 10+ years of direct clinical and regulatory experience in medical devices • Experience with Active Implantable Medical Devices • Minimum bachelor's degree in science, biomedical, or health-related field • Success developing clinical evidence strategies and designing and conducting clinical trials for medical devices and/or pharmaceuticals • Experience synthesizing complex clinical data into understandable written formats • Experience with neurostimulation industry preferred • Experience working with FDA and/or other regulatory and governmental agencies desired • Excellent verbal and written communication • Ability to think creatively and dynamically and foster commitment to thoughtful science • Knowledge of ICH/GCP and FDA medical device regulations • Knowledge of electronic data capture systems and web-based clinical trial management tools • Knowledge of research design, data analysis, and biostatistics • Self-motivated and able to work independently, initiate assignments, and follow through • Ability to develop interpersonal relationships with medical professionals • Excellent organizational skills and attention to detail • High degree of personal integrity • Ability to work effectively across time zones and cultures • Ability to travel domestically and internationally

🏖️ Benefits

• Ability to work effectively across time zones and cultures • Domestic travel limited to 10% of time • International travel opportunities/requirements • Diversity and equal opportunity commitment • High-performance culture centered on customer focus, creative problem solving, transparency, and partnership