Manager Clinical Affairs

Accountabilities:: Lead clinical study programs: Plan, implement, manage, and report assigned clinical studies in alignment with the broader clinical research and evidence-generation strategy. Establish and manage program plans: Define detailed timelines, milestones, and objectives; monitor execution, assess risks, and implement mitigation strategies to ensure successful delivery. Oversee clinical quality and compliance: Develop, maintain, and optimize clinical quality systems, clinical regulatory processes, and data integrity and quality practices. Coordinate internal and external stakeholders: Direct and collaborate with cross-functional teams, external staff, clinical sites, and physicians to ensure studies are conducted effectively and consistently with organizational objectives. Develop clinical study documentation: Prepare and contribute to study protocols, statistical analysis plans, clinical reports, and other essential study materials. Support clinical affairs strategy: Contribute to the strategic direction, development, and implementation of clinical affairs objectives, processes, and operational practices. Contribute to scientific communication: Support the preparation of manuscripts, abstracts, data presentations, and other materials that communicate clinical evidence. Advance health-economic initiatives: Contribute to initiatives that demonstrate the clinical and economic value of the therapy. Drive issue resolution: Lead the identification, assessment, and resolution of clinical program issues, promoting thoughtful and timely problem-solving. Promote a high-performance culture: Encourage customer focus, scientific rigor, transparency, accountability, collaboration, and continuous improvement across the clinical affairs function. Requirements: Relevant professional experience: At least five years of direct clinical and regulatory experience in the medical device industry, including some experience with active implantable medical devices. Clinical trial leadership: Demonstrated success in designing and conducting clinical trials supporting medical devices and/or pharmaceutical products. Industry experience: Experience in the neurostimulation industry is preferred. Regulatory experience: Experience working with the U.S. Food and Drug Administration (FDA) and/or other regulatory or governmental agencies is desirable. Education: Bachelor's degree or higher in a science, biomedical, health-related, or comparable field. A master's degree or PhD is preferred. Clinical data communication: Ability to synthesize complex clinical data and communicate findings clearly through well-structured written materials. Regulatory and clinical standards: Knowledge of ICH-GCP guidelines and FDA medical device regulations. Research and statistical knowledge: Understanding of clinical research design, data analysis, and biostatistics. Clinical systems: Familiarity with electronic data capture systems and web-based clinical trial management tools. Communication skills: Excellent written and verbal communication skills, with the ability to build effective relationships with physicians and other medical professionals. Interpersonal effectiveness: Confidence, professional credibility, and the ability to collaborate with diverse stakeholders across different time zones and cultures. Organization and attention to detail: Strong organizational skills and the ability to manage complex activities with accuracy. Autonomy and initiative: Self-motivated, independent working style, with the ability to initiate assignments, take ownership, and follow through to completion. Problem-solving and adaptability: Creative and dynamic approach to challenges, with a commitment to thoughtful science and improving outcomes for patients. Professional integrity: High degree of personal integrity and commitment to ethical, patient-focused work. Travel availability: Ability to travel domestically approximately 10% of the time and internationally as required. Benefits: Full-time employment. Remote working arrangement, with the position listed in Minneapolis, Minnesota. Opportunity to contribute to clinical research and evidence generation for an innovative implantable neuromodulation therapy. Collaborative, cross-functional working environment involving clinical, scientific, regulatory, and operational teams. Opportunity to contribute to work focused on improving treatment options and patient outcomes.