Head of Clinical and Medical Affairs
RemoteUnited States or Minneapolis, Minnesota, United States
Job Summary
Lead the Clinical Research and Evidence Strategy by collaborating with Commercial and R&D teams to support Saluda's scientific needs and business strategy. Partner closely with Regulatory Affairs, Commercial, and R&D stakeholders to ensure alignment of medical, clinical, product portfolio, and business objectives. Oversee investigator-initiated research programs, conference presence through abstracts and presentations, and the publication planning process for timely dissemination of scientific data. Own the clinical quality system, regulatory requirements, data integrity, and clinical operations while managing customer Medical Information requests in accordance with applicable regulations. Build and lead the Clinical and Medical Affairs functions to establish the company's credible scientific voice, bridging internal functions with the external medical and scientific community.
Required Qualifications
- 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
- 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 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
- Ability to work effectively across time zones and cultures
- Ability to travel domestically (20% of time) and internationally
Desired Qualifications
- PhD
- Experience with neurostimulation industry
- Active implantable experience in neuromodulation field
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.