Head of Clinical and Medical Affairs

Saluda Medical

About The Position

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.

Requirements

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 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

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 (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