Manager Clinical Affairs

Saluda Medical; Minneapolis (MN); On-site; USD 140,000 - 200,000; Full time

Job summary

Saluda Medical, a Minneapolis-based medical device company, seeks a seasoned clinical/regulatory leader to shape the clinical quality system and regulatory strategy. You will drive protocol development, data integrity, and collaboration with sites and physicians to ensure compliant clinical programs.

You will design and oversee protocols, analysis plans, and reports, while supporting manuscripts and health economics initiatives.

Qualifications

• 5+ years direct clinical and regulatory experience in medical devices.
• Experience with Active Implantable Medical Devices is a plus.
• Experience with FDA and regulatory agencies desired.
• Ability to translate complex clinical data into understandable written reports.

Responsibilities

• Develop, maintain, and optimize the clinical quality system, regulatory requirements, and data integrity/quality.
• Establish detailed program plans, drive execution, assess risk and ensure delivery of clinical objectives.
• Coordinate with internal/external staff, partner sites and physicians for compliant clinical programs.
• Develop protocols, statistical analysis plans, reports, and other clinical study documentation.
• Contribute to strategic direction for clinical affairs objectives and processes.
• Support manuscripts, abstracts, data presentations, and health economic initiatives.
• Promote a high-performance culture and drive issue identification and resolution.

Skills

Clinical regulatory

Medical device regulations

Data integrity

Cross-functional collab

Travel ready

Education

Bachelor’s degree in science/biomedical/health

Masters or PhD preferred

Job description

Saluda Medical is a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed-loop neuromodulation platform. The company’s proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real-time neurophysiological feedback.

Saluda Medical’s first product, the Evoke System, is designed to deliver known, consistent, and personalized spinal cord stimulation therapy by objectively measuring neural responses and maintaining therapy within a prescribed therapeutic window. Saluda Medical is headquartered in Minneapolis, Minnesota.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient’s lives.

What You'll Do:

• Development, maintenance, and optimization of the clinical quality system, clinical regulatory requirements, and data integrity/quality
• Establish detailed program plans, drive program execution toward established objectives, assess risk and implement strategies to ensure successful delivery of the clinical objectives
• Direct and collaborate with internal and external staff, and liaise with partner sites and physicians, to ensure successful conduct of assigned clinical programs consistent with company objectives and applicable regulations and policies
• Development of protocols, statistical analysis plans, reports and other clinical study documentation
• Contribute to the overall strategic direction for development and implementation of clinical affairs objectives and processes
• Support and contribute to manuscripts, abstracts, data presentations, and health economic value initiatives
• Promote and embody culture and behavior expectations of a high-performance culture
• Drives leadership of issue identification and resolution

What You'll Bring:

• 5+ years direct clinical and regulatory experience in medical devices including some experience with Active Implantable Medical Devices. Demonstrated success in designing and conducting clinical trials in support of medical device and/or pharmaceuticals. Experience with neurostimulation industry preferred
• Experience working with FDA and/or other regulatory and governmental agencies desire
• Experience in synthesizing complex clinical data into understandable written format
• A minimum of a Bachelor’s degree in science/biomedical/health related field; Masters or PhD preferred
• Ability to work effectively across time zones and cultures
• Ability to travel domestically (10% of time) and internationally

Knowledge/Skills/Abilities:

• Excellent verbal and written communication Knowledge of ICH/GCP and FDA medical device regulations Knowledge of research design, data analysis and biostatistics Self-assured, knowledgeable professional capable of developing good interpersonal relationships with medical professionals High degree of personal integrity
• Excellent organizational skills and attention to detail
• Self-motivated and 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, dynamically, and foster a culture of commitment to thoughtful science to help patients in need

Our Core Values:

• People – Our first responsibility is to the patients we serve.
• Integrity – Do the right thing
• Pioneering – Lead Boldly, Change Lives, Disrupt the Status-Quo
• Performance – Win together – Deliver with Excellence.

Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation.

Saluda Medical does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Saluda Medical’s approved agency list. Unsolicited resumes or candidate information submitted to Saluda Medical by search/recruiting agencies not already on Saluda Medical’s approved agency list shall become the property of Saluda Medical.