Head of Clinical and Medical Affairs

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 objectivesExternal communication of the scientific foundations of and evidence associated with the Saluda systemDevelop and maintain key thought leader and society relationshipsOversee the development and execution of the investigator-initiated research program and investigator-initiated studiesOversee the execution of the conference presence through abstracts, posters, and presentationsOversee and lead the publication planning process, ensuring timely and accurate dissemination of scientific data through publicationsOwner of the clinical quality system, clinical regulatory requirements, data integrity/quality, and oversee clinical operationsProcess 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 informationLead the team with a high degree of integrity, professionalism, accountability, and an environment of mutual respectProvide excellent communication and reporting both cross-functionally and to senior managementWill 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 DevicesA minimum of a Master's degree in science/biomedical/health related field; PhD preferredExperience with neurostimulation industry preferredActive implantable experience in neuromodulation field preferredDemonstrated success in working with FDA and/or other regulatory and governmental agenciesDemonstrated 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 scienceExcellent verbal and written communicationAbility to think creatively, dynamically, and foster a culture of commitment to thoughtful science to help patients in needDemonstrated leadership experience, including excellent strategic, analytical, planning, and communication skills in a dynamic, fast-paced environmentLeadership style that demonstrates professionalism, encourages accountability, and establishes an environment of mutual respectMaturity, confidence and credibility to advise and influence senior managementExcellent organizational and project management skills with a high degree of attention to detailHigh degree of personal integrity Additional Expectations: Ability to work effectively across time zones and culturesAbility 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 thingPioneering – Lead Boldly, Change Lives, Disrupt the Status-QuoPerformance – 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.