Manager, Clinical Affairs

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

📋 Description

• Contribute to the development of the clinical research and evidence generation strategy.

• Plan, execute, manage, and report on relevant clinical studies and related 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 a Class III implantable electrical stimulation therapy.

• Drive program execution to fulfill customer needs and achieve financial objectives.

• Foster a high-performance culture focused on customer orientation, innovative problem solving, transparency, and collaboration.

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

• Create detailed program plans and steer execution towards defined goals.

• Evaluate risks and implement strategies to guarantee successful completion of clinical objectives.

• Direct and collaborate with internal and external personnel and coordinate with partner sites and physicians.

• Develop protocols, statistical analysis plans, reports, and other documentation for clinical studies.

• Contribute to the strategic direction for clinical affairs objectives and processes.

• Support the preparation of manuscripts, abstracts, data presentations, and health economic value initiatives.

• Lead the identification and resolution of issues.

⛳️ Requirements

• Over 5 years of direct clinical and regulatory experience in medical devices, with some exposure to Active Implantable Medical Devices.

• Proven success in designing and conducting clinical trials to support medical devices and/or pharmaceuticals.

• Preferred experience in the neurostimulation industry.

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

• Experience in synthesizing complex clinical data into clear and comprehensible written formats.

• A minimum of a Bachelor’s degree in a science, biomedical, or health-related field.

• A Master's degree or PhD is preferred.

• Ability to work efficiently across different time zones and cultures.

• Willingness to travel domestically (10% of the time) and internationally.

• Exceptional verbal and written communication skills.

• Knowledge of ICH/GCP and FDA regulations concerning medical devices.

• Understanding of research design, data analysis, and biostatistics.

• Capability to build strong interpersonal relationships with medical professionals.

• High personal integrity and excellent organizational skills with a keen attention to detail.

• Self-motivated with an independent work style, capable of initiating and completing assignments.

• Familiarity with electronic data capture systems and web-based clinical trial management tools.

• Ability to think creatively and dynamically while promoting a culture committed to rigorous scientific inquiry.

🏝️ Benefits

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

• Potential for domestic (10% of the time) and international travel.

• Commitment to diversity and equal opportunity in the workplace.