Head of Clinical and Medical Affairs Saluda Medical

• 4.

2 Minnetonka, MN Job Details Full-time 3 hours ago Qualifications Customer communication Master's degree Clinical research compliance Regulatory affairs Biomedical regulatory compliance Medical affairs Full Job Description Saluda Medical is a commercial‑stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed‑loop neuromodulation platform. The company's proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real‑time neurophysiological feedback. Saluda Medical's first product, the Evoke® System, is designed to deliver known, consistent, and personalized spinal cord stimulation therapy by objectively measuring neural responses and maintaining therapy within a prescribed therapeutic window. Saluda Medical is headquartered in Minneapolis, Minnesota. At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient's lives. The Head of Clinical and Medical Affairs position is a pivotal strategic leadership role responsible for the establishment and direction of the clinical and medical affairs functions globally as well as overseeing all medical and clinical activities across the organization. This executive will liaise with key customers and research collaborators, develop clinical research and evidence generation strategy, communicate the scientific foundations of and evidence associated with the Saluda system. They will build, lead, and develop the Clinical and Medical Affairs functions in a fast-paced, dynamic environment, ensuring that all initiatives align with the company's evidence generation, therapy and clinical development, regulatory and commercial strategies. The primary objective is to develop and lead a team that provides for the credible scientific voice of the company, bridging the gap between internal functions and the external medical and scientific community to ultimately benefit patients.

What You'll Do:

Lead the Clinical Research and Evidence Strategy and collaborate with Commercial (and other) teams on the evidence generation and communications plan supporting Saluda's scientific needs and business strategy (i.e. relating to clinical studies, scientific publications, abstracts and conference presence) Partner closely with internal stakeholders across Regulatory Affairs, Commercial, and R D teams to ensure alignment of medical, clinical, product portfolio and business objectives External communication of the scientific foundations of and evidence associated with the Saluda system Develop and maintain key thought leader and society relationships Oversee the development and execution of the investigator-initiated research program and investigator-initiated studies Oversee the execution of the conference presence through abstracts, posters, and presentations Oversee and lead the publication planning process, ensuring timely and accurate dissemination of scientific data through publications Owner of the clinical quality system, clinical regulatory requirements, data integrity/quality, and oversee clinical operations Process owner and oversight of customer requests for Medical Information (MI) in accordance with applicable regulations, including product use, off-label use, patient data, publications and safety information Lead the team with a high degree of integrity, professionalism, accountability, and an environment of mutual respect Provide excellent communication and reporting both cross-functionally and to senior management Will ensure team have clear objectives consistent with company objectives

What You'll Bring:

15+ years direct clinical and/or medical affairs experience in medical devices including experience with Active Implantable Medical Devices A minimum of a Master's degree in science/biomedical/health related field; PhD preferred Experience with neurostimulation industry preferred Active implantable experience in neuromodulation field preferred Demonstrated success in working with FDA and/or other regulatory and governmental agencies Demonstrated success in developing clinical evidence strategies, and designing and conducting clinical trials in support of medical device and/or pharmaceuticals

Knowledge/Skills/Abilities:

Knowledge of neuroscience and/or biomedical science Excellent verbal and written communication Ability to think creatively, dynamically, and foster a culture of commitment to thoughtful science to help patients in need Demonstrated leadership experience, including excellent strategic, analytical, planning, and communication skills in a dynamic, fast-paced environment Leadership style that demonstrates professionalism, encourages accountability, and establishes an environment of mutual respect Maturity, confidence and credibility to advise and influence senior management Excellent organizational and project management skills with a high degree of attention to detail High degree of personal integrity

Additional Expectations:

Ability to work effectively across time zones and cultures Ability to travel domestically (20% of time) and internationally

Our Core Values:

People

• Our first responsibility is to the patients we serve. Integrity
• Do the right thing Pioneering
• Lead Boldly, Change Lives, Disrupt the Status-Quo Performance
• Win together
• Deliver with Excellence.

Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation. Saluda Medical does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Saluda Medical's approved agency list. Unsolicited resumes or candidate information submitted to Saluda Medical by search/recruiting agencies not already on Saluda Medical's approved agency list shall become the property of Saluda Medical.