Manager Clinical Affairs

Saluda Medical • Minneapolis, MN

1d

About The Position

Saluda Medical is a commercial-stage medical device company developing treatments for chronic neurological conditions through its closed-loop neuromodulation platform. Its first product, the Evoke® System, delivers personalized spinal cord stimulation therapy by measuring neural responses and adjusting therapy using real-time neurophysiological feedback. Saluda Medical is headquartered in Minneapolis, Minnesota.

The Manager, Clinical Affairs is central to the company’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 related regulatory activities in accordance with that strategy. The manager works with cross-functional teams and external partners to support global market access and adoption of a class III implantable electrical stimulation therapy. The role also drives program execution to meet customer needs and business financial goals while fostering a high-performance culture centered on customer focus, 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 build effective 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.
• A master’s degree or PhD in a science, biomedical, or health-related field.

Responsibilities

• Develop, maintain, and optimize the clinical quality system, clinical regulatory requirements, and data integrity and quality.
• Establish detailed program plans, drive execution toward objectives, assess risks, and implement strategies to ensure successful delivery of clinical objectives.
• Direct and collaborate with internal and external staff and liaise with partner sites and physicians to ensure clinical programs are conducted successfully and consistently with company objectives, regulations, and policies.
• Develop clinical study protocols, statistical analysis plans, reports, and other 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 expectations for a high-performance culture.
• Lead identification and resolution of issues.

What This Job Offers

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