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Minneapolis, Minnesota, United States
Remote only
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Clinical Affairs based in the United States.
This is a leadership opportunity to shape and deliver clinical research programs for an innovative medical device platform focused on treating chronic neurological conditions. As Manager, Clinical Affairs, you will help define clinical evidence-generation strategies and oversee the planning, execution, and reporting of clinical studies. You will collaborate with multidisciplinary teams and external clinical partners to ensure studies meet scientific, operational, and regulatory expectations. Your work will contribute to demonstrating the safety, performance, and value of an advanced implantable neuromodulation therapy. You will also support regulatory activities, clinical publications, and health-economic initiatives that help enable global market access and adoption. This role combines scientific rigor, strategic thinking, and hands-on program leadership in a patient-focused, high-performance environment.
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.
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.
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.