Manager, Clinical Affairs

Regulatory Jobs; Minneapolis (MN); Presencial; USD 150 000 - 210 000; Tempo integral

Resumo da oferta

Saluda Medical, a Minneapolis-based, commercial-stage medical device company, seeks a Manager, Clinical Affairs to lead its clinical study program and global regulatory activities.

You will shape the clinical research strategy and oversee planning, execution, and reporting in collaboration with R&D, Regulatory, and Medical Affairs to support market access for a novel class III implantable neuromodulation therapy.

Qualificações

• Bachelor’s degree in science/biomedical/health related field required; advanced degree preferred.
• 5+ years clinical and regulatory experience in medical devices.
• Experience with Active Implantable Medical Devices and FDA regulation desirable.

Responsabilidades

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

Conhecimentos

Clinical trial design

Regulatory affairs

FDA regulatory experience

Neurostimulation (preferred)

Cross-functional leadership

Formação académica

Bachelor's degree in science/biomedical/health related field

Masters or PhD preferred

Ferramentas

EDC systems

Descrição da oferta de emprego

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 Manager, 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
• 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.