Global Clinical Safety Program Lead

Abbott; Maple Grove (MN); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

High employer retirement contribution

Tuition reimbursement and FreeU degree

Global employer with diverse career

Job summary

Abbott is seeking a Clinical Safety Program Lead to drive global studies from start-up through closeout, delivering safety oversight, high-quality data, and regulatory compliance across the portfolio. You will partner with Safety leadership to ensure studies move forward efficiently with patient safety at the forefront.

You will collaborate with Clinical Operations, Regulatory Affairs, Medical Affairs, and Biostatistics to mitigate risk, improve processes, and mentor teams in a culture of

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.

Responsibilities

• 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 elevate 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 elevate 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.

Skills

Communication

Leadership

Problem-solving

Education

Bachelor's degree in nursing, Pharmacy, Life Sciences, Biomedical Engineering, Public Health, or related field

Job description

Abbott is seeking a Clinical Safety Program Lead to drive global studies from start-up through closeout, delivering safety oversight, high-quality data, and regulatory compliance across the portfolio. You will partner with Safety leadership to ensure studies move forward efficiently with patient safety at the forefront.

You will collaborate with Clinical Operations, Regulatory Affairs, Medical Affairs, and Biostatistics to mitigate risk, improve processes, and mentor teams in a culture of