Director, Clinical Affairs

Regulatory Toolkit; Minneapolis (MN); On-site; USD 180,000 - 240,000; Full time

Job summary

Saluda Medical seeks a Director, Clinical Affairs to lead the clinical study program and regulatory activities across global markets. You will define strategy, plan studies, manage regulatory interactions, and collaborate with R&D, Marketing, Clinical Operations, Medical Affairs, and Regulatory Affairs to enable market access for a novel class III implantable neuromodulation therapy.

You will drive execution, ensure data integrity, and contribute to manuscripts and health economic initiatives

Qualifications

• 10+ years direct clinical and regulatory experience in medical devices
• Bachelor’s degree; advanced degree preferred
• Experience in developing clinical evidence strategies and conducting clinical trials
• Experience with FDA and regulatory agencies
• Experience with neurostimulation industry preferred

Responsibilities

• Develop, maintain, and optimize the clinical quality system and regulatory requirements; ensure data integrity
• Create program plans and drive execution toward objectives; assess risk and strategies
• Contribute to strategic direction for clinical affairs objectives and processes
• Direct and collaborate with internal and external staff for successful clinical programs
• Develop protocols, SAPs, reports and other clinical study documentation
• Support manuscripts, abstracts, data presentations, and health economic initiatives
• Promote a high-performance culture and cross-functional collaboration
• Lead issue identification and resolution across programs

Skills

Clinical regulatory

Active implantables

FDA knowledge

Clinical trials design

Data synthesis

Education

Bachelor’s degree in science/biomedical/health

Masters or PhD preferred

Tools

EDC systems

Clinical trial management tools

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.

In this exciting role as a Director, Clinical Affairs, you will be at the center of Saluda’s clinical study program. Your insights will contribute to formulating the clinical research and evidence generation strategy, and you will be responsible for the planning, implementation, managing, and reporting of the applicable clinical studies and associated regulatory activities in accordance with that strategy. To achieve this you will collaborate with a cross-functional team, including Research and Development, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality and Operations, enabling global market access and adoption of a new class III implantable electrical stimulation therapy worldwide. While driving program execution to meet customer needs and financial goals of the business, you will create and uphold a high-performance culture centered on customer focus, creative and determined problem solving, transparency and partnership.

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
• Contribute to the overall strategic direction for development and implementation of clinical affairs objectives and processes
• Direct and collaborate with internal and external staff to assure 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
• 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:

• 10+ years direct clinical and regulatory experience in medical devices including some experience with Active Implantable Medical Devices
• A minimum of a Bachelor’s degree in science/biomedical/health related field; Masters or PhD preferred
• Demonstrated success in developing clinical evidence strategies, and designing and conducting clinical trials in support of medical device and/or pharmaceuticals
• Experience in synthesizing complex clinical data into understandable written format
• Experience with neurostimulation industry preferred
• Experience working with FDA and/or other regulatory and governmental agencies desired

Knowledge/Skills/Abilities:

• Excellent verbal and written communication
• Ability to think creatively, dynamically, and foster a culture of commitment to thoughtful science to help patients in need
• Knowledge of ICH/GCP and FDA medical device regulations
• Knowledge of electronic data capture systems and web-based clinical trial management toolsKnowledge of research design, data analysis and biostatistics
• Self-motivated and independent work style with the ability to initiate and follow through on assignments
• Self-assured, knowledgeable professional capable of developing good interpersonal relationships with medical professionals
• Excellent organizational skills and attention to detail
• High degree of personal integrity

Additional Expectations:

• Ability to work effectively across time zones and cultures
• Ability to travel domestically (10% of time) and internationally

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.