Manager Clinical Affairs

Saluda Medical • Minneapolis, MN

3d

About The Position

Saluda Medical is a commercial-stage medical device company focused on treatments for chronic neurological conditions using a closed-loop neuromodulation platform. Its technology measures neural responses to stimulation and adjusts therapy based on real-time neurophysiological feedback. The company’s first product, the Evoke® System, delivers personalized spinal cord stimulation therapy by measuring neural responses and maintaining therapy within a prescribed therapeutic window. Saluda Medical is headquartered in Minneapolis, Minnesota.

The Manager, Clinical Affairs is central to Saluda’s clinical study program. The role contributes to clinical research and evidence-generation strategy and is responsible for planning, implementing, managing, and reporting applicable clinical studies and associated regulatory activities. Working cross-functionally with Research and Development, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality, and Operations, the Manager supports global market access and adoption of a new class III implantable electrical stimulation therapy. The role drives program execution to meet customer needs and business financial goals while promoting a high-performance culture focused on customer service, creative problem-solving, transparency, and partnership.

Requirements

• At least 5 years of direct clinical and regulatory experience in medical devices, including some experience with active implantable medical devices.
• Demonstrated success designing and conducting clinical trials supporting medical devices and/or pharmaceuticals.
• Bachelor’s degree or higher in a science, biomedical, or health-related field.
• Ability to work effectively across time zones and cultures.
• Ability to travel domestically (10% of the time) and internationally.
• Excellent verbal and written communication skills.
• Knowledge of ICH/GCP and FDA medical device regulations.
• Knowledge of research design, data analysis, and biostatistics.
• Ability to develop good interpersonal relationships with medical professionals.
• High degree of personal integrity.
• Excellent organizational skills and attention to detail.
• Self-motivated, independent work style, with the ability to initiate and follow through on assignments.
• Knowledge of electronic data capture systems and web-based clinical trial management tools.
• Ability to think creatively and dynamically and foster commitment to thoughtful science that helps patients.

Nice To Haves

• Experience in the neurostimulation industry.
• Experience working with the FDA and/or other regulatory and governmental agencies.
• Master’s degree or PhD.

Responsibilities

• Develop, maintain, and optimize the clinical quality system, clinical regulatory requirements, and data integrity and quality.
• Establish detailed program plans, drive execution toward established objectives, assess risks, and implement strategies to deliver clinical objectives successfully.
• Direct and collaborate with internal and external staff, and liaise with partner sites and physicians, to ensure assigned clinical programs are conducted successfully and consistently with company objectives and applicable regulations and policies.
• Develop protocols, statistical analysis plans, reports, and other clinical study documentation.
• Contribute to the strategic direction and implementation of clinical affairs objectives and processes.
• Support and contribute to manuscripts, abstracts, data presentations, and health economic value initiatives.
• Promote and embody the behaviors and expectations of a high-performance culture.
• Lead identification and resolution of issues.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager