Head of Clinical and Medical Affairs

About the Company

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, innovate beyond the conventional, and aim to revolutionize the standard of care in neuromodulation to positively impact patients' lives.

About the Role

This 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. The Head of Clinical and Medical Affairs will liaise with key customers and research collaborators, develop clinical research and evidence generation strategy, and communicate the scientific foundations of and evidence associated with the Saluda system.

The primary objective is to develop and lead a team that provides the credible scientific voice of the company, bridging the gap between internal functions and the external medical and scientific community to ultimately benefit patients.

Responsibilities

• 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 (e.g., 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.
• Oversee 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.
• Lead the publication planning process, ensuring timely and accurate dissemination of scientific data through publications.
• Own the clinical quality system, clinical regulatory requirements, data integrity/quality, and oversee clinical operations.
• Serve as process owner and oversight for 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.
• Ensure the team has clear objectives consistent with company objectives.

Requirements

• 15+ years of 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 the neurostimulation industry preferred.
• Active implantable experience in the 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 devices and/or pharmaceuticals.

Skills

• Knowledge of neuroscience and/or biomedical science.
• Excellent verbal and written communication.
• Ability to think creatively and dynamically, fostering 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.

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.