JOB DESCRIPTION:The Opportunity The Clinical Safety Program Lead combines clinical study leadership, project management, and medical safety oversight to drive the successful execution of global clinical investigations. Serving as both the operational portfolio lead and study-level safety expert, this role partners closely with Safety leadership and ensures studies are delivered efficiently while maintaining the highest standards of subject safety, scientific integrity, data quality, and regulatory compliance across the assigned portfolio. The individual is responsible for driving operational decisions, identifying gaps, developing solutions, and leading end-to-end data quality and safety processes. This individual anticipates and mitigates risks, proactively escalates and resolves issues, and drives execution against critical timelines in partnership with cross-functional stakeholders. A key focus of the role is supporting ongoing priority studies while leading execution of upcoming IDE clinical investigations, ensuring consistent, inspection-ready delivery and successful clinical development outcomes across the portfolio.
The ideal candidate brings a unique blend of clinical research operations experience, project management expertise, and clinical or medical knowledge, enabling them to lead complex studies, evaluate safety data, influence cross-functional decision-making, and provide strategic guidance throughout the clinical development lifecycle. They are recognized as a trusted team member who can balance operational execution with safety oversight while fostering accountability, collaboration, and continuous process improvement, in partnership with Safety leadership.
What You'll Work On- Lead the operational execution and safety oversight of global clinical studies from start-up through study closeout.
- Serve as the primary safety lead for assigned portfolio, providing expert assessment of safety data, emerging trends, and potential risks.
- Support operational decision-making by identifying gaps, developing solutions, and influencing cross-functional teams.
- Develop and implement study-specific safety management strategies and risk mitigation plans.
- Identify operational risks and implement mitigation strategies to maintain study timelines and quality standards and escalate risk to leadership.
- Lead end-to-end data review, data cleaning, and quality initiatives to ensure accurate, reliable, and inspection-ready study data.
- Partner with Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and Product Development to ensure successful study execution.
- Oversee external committees including Data Monitoring Committees and Clinical Events Committees.
- Drive protocol development, study design, endpoint definitions, and safety monitoring approaches across assigned portfolio.
- Ensure timely and compliant safety reporting to regulatory authorities, investigators, ethics committees, and internal stakeholders.
- Provide clinical interpretation of safety data and support regulatory submissions, clinical study reports, and health authority interactions.
- Drive inspection readiness, process improvements, and best practices across clinical operations and safety functions.
- Mentor team members and contribute to a culture of collaboration, accountability, continuous improvement, and patient focus.
- Anticipate study risks, proactively identify issues, and escalate critical concerns to ensure timely resolution.
- Maintain awareness of emerging clinical evidence, disease-state developments, and competitive technologies.
- Establish and drive study timelines, deliverables, and action plans while holding teams accountable for execution.
- Contribute to development and revision of SOPs, work instructions, and best practices.
Required Qualifications- Bachelor's degree in nursing, Pharmacy, Life Sciences, Biomedical Engineering, Public Health, or related field.
- 5+ years of clinical research experience.
- Experience leading global clinical studies and cross-functional teams.
- Experience in clinical safety, pharmacovigilance, medical monitoring, or safety surveillance.
- Experience in project management role or equivalent
- Strong knowledge of GCP, ISO 14155, FDA regulations, MDR, and global clinical research requirements.
- Excellent communication, leadership, and problem-solving skills.
Preferred Qualifications:- Advanced clinical degree (MD, PharmD, DNP, NP, PA-C, MSN, PhD, or equivalent).
- Medical device, structural heart, vascular, or cardiac rhythm therapeutic area experience.
- Experience serving as a Medical Monitor, Safety Lead, or Clinical Safety professional.
- PMP certification or advanced project management training.
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The base pay for this position is $99,300.00 - $198,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Medical & Scientific Affairs
DIVISION:MD Medical Devices
LOCATION:United States > Maple Grove : 6820 Wedgwood Road N.
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 20 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
