Clinical Specialist, U.S. (Medical Affairs)
Reports To: Vice President, Medical Affairs
Location: United States (field-based)
Travel: Up to ~80% domestic
About the Role
The Clinical Specialist plays a dual role: (1) delivering high-quality clinical and medical education to internal teams and external clinicians, and (2) partnering with a CRO to help execute a U.S. post-approval study of the Allurion Smart Capsule. You will be a trusted expert in patient safety, education, and clinical rigor—elevating clinical outcomes, ensuring compliance, and maintaining safety.
What You’ll Do
1. Medical Education, Training & Proctoring
• Serve on the global proctoring team; plan and deliver medical training for internal personnel and external clinicians (live, virtual, and hands-on).
• Proctor clinical cases to reinforce best practices and patient safety; ensure adherence to the Allurion Instructions for Use (IFU).
• Develop clear, evidence-based training content, job aids, and assessments that drive competency and consistency.
2. Clinical Operations & Study Execution
• Lead day-to-day collaboration with the CRO to execute the U.S. post-approval study, managing timelines, risks, and deliverables.
• Partner with the Principal Investigator(s) to communicate study status, milestones, and issues; provide consistent, concise updates to internal stakeholders.
• Oversee quality checks across the study lifecycle to uphold Company SOPs, ICH-GCP, applicable regulatory standards, and patient safety.
• Support regulatory activities and dossier development; participate in FDA interactions as requested.
• Drive inspection readiness with study sites and adopt proactive approaches to regulatory inspections.
3. Quality, Safety & Cross-Functional Partnership
• Perform site audits to evaluate best practices and compliance with Company SOPs and the Allurion IFU.
• Partner with internal teams to ensure product complaints are recorded and reported per SOPs and patient safety standards.
• Champion continuous improvement; surface insights from training and field activity to inform product, clinical, and medical strategy.
What You Bring
Required
• Bachelor’s degree in a scientific/clinical discipline or related field.
• 5+ years of experience in medical education and managing clinical trials (medical device preferred), with strong command of ICH-GCP and U.S. regulatory practices.
• Demonstrated strength in teaching/presenting and technical writing.
• Proven ability to thrive in a fast-paced, dynamic environment and support cross-functional goals.
• Ability to travel domestically up to ~80%.
Preferred
• Experience in gastroenterology or metabolic disease.
• Experience delivering medical device training and proctoring; familiarity with vendor/CRO management.