Head of Clinical and Medical Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Establish and lead the global clinical and medical affairs functions.

• Supervise all medical and clinical operations within the organization.

• Direct clinical research and evidence strategy while collaborating on evidence generation and communication plans.

• Collaborate with Regulatory Affairs, Commercial, and R&D teams to ensure alignment of medical, clinical, product portfolio, and business goals.

• Articulate the scientific basis and evidence related to the Saluda system.

• Cultivate and maintain relationships with key thought leaders and professional societies.

• Manage investigator-initiated research and studies.

• Oversee the organization's presence at conferences through abstracts, posters, and presentations.

• Direct publication planning and the dissemination of scientific data.

• Take ownership of the clinical quality system, clinical regulatory requirements, data integrity/quality, and clinical operations.

• Manage customer inquiries for Medical Information in compliance with relevant regulations.

• Build, lead, and nurture the Clinical and Medical Affairs team.

• Promote a culture of integrity, professionalism, accountability, and mutual respect.

⛳️ Requirements

• Over 15 years of direct experience in clinical and/or medical affairs within the medical device sector.

• Familiarity with active implantable medical devices.

• A minimum of a Master's degree in a scientific, biomedical, or health-related discipline.

• PhD is preferred.

• Experience in the neurostimulation industry is desirable.

• Background in active implantable devices specifically within the neuromodulation field is preferred.

• Proven track record of success working with the FDA and/or other regulatory and governmental bodies.

• Demonstrated ability to develop clinical evidence strategies and design and conduct clinical trials for medical devices and/or pharmaceuticals.

• Knowledge of neuroscience and/or biomedical science.

• Exceptional verbal and written communication skills.

• Proven leadership experience, showcasing strategic, analytical, planning, and communication capabilities.

• Outstanding organizational and project management skills with a keen eye for detail.

• High level of personal integrity.

• Capability to work effectively across various time zones and cultures.

• Willingness to travel domestically (20% of the time) and internationally.

🏝️ Benefits

• Ability to work effectively across time zones and cultures.

• Opportunity for domestic (20% of the time) and international travel.

• Commitment to diversity and equal opportunity.