Director, Clinical Affairs

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

📋 Description

• Develop and execute strategies for clinical research and evidence generation.

• Plan, implement, oversee, and report on relevant clinical studies and regulatory activities.

• Collaborate with teams across Research and Development, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality, and Operations.

• Facilitate global market access and adoption of Saluda Medical's class III implantable electrical stimulation therapy.

• Create, maintain, and enhance the clinical quality system, regulatory requirements, and ensure data integrity and quality.

• Formulate comprehensive program plans and drive execution toward defined objectives.

• Evaluate risks and develop strategies to guarantee successful clinical outcomes.

• Contribute to the strategic vision and execution of clinical affairs goals and processes.

• Lead and collaborate with both internal and external personnel to carry out assigned clinical programs.

• Prepare protocols, statistical analysis plans, reports, and various clinical study documentation.

• Assist with manuscripts, abstracts, data presentations, and health economic value initiatives.

• Foster and exemplify a high-performance culture and behavioral expectations.

• Guide issue identification and resolution efforts.

⛳️ Requirements

• Over 10 years of direct experience in clinical and regulatory aspects pertaining to medical devices.

• Background in Active Implantable Medical Devices is essential.

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

• Proven success in formulating clinical evidence strategies and designing and executing clinical trials for medical devices and/or pharmaceuticals.

• Proficient in synthesizing complex clinical data into clear and accessible written formats.

• Experience in the neurostimulation industry is preferred.

• Familiarity with FDA and/or other regulatory and governmental agencies is desired.

• Exceptional verbal and written communication skills.

• Ability to think innovatively and dynamically while promoting commitment to rigorous scientific standards.

• Understanding of ICH/GCP guidelines and FDA regulations related to medical devices.

• Knowledge of electronic data capture systems and web-based clinical trial management tools.

• Proficient in research design, data analysis, and biostatistics.

• Self-driven and capable of working independently, initiating tasks, and following through.

• Ability to cultivate interpersonal relationships with healthcare professionals.

• Outstanding organizational skills and meticulous attention to detail.

• High level of personal integrity.

• Competence in working effectively across different time zones and cultural environments.

• Willingness to travel domestically and internationally.

🏝️ Benefits

• Ability to work effectively across time zones and cultures.

• Domestic travel is limited to 10% of the time.

• Opportunities and requirements for international travel.

• Commitment to diversity and equal opportunity.

• A high-performance culture focused on customer-centricity, creative problem-solving, transparency, and collaboration.