Senior Global Clinical Safety Lead

Abbott Laboratories; Santa Clara (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott Laboratories in Santa Clara, CA, is seeking a Clinical Safety Program Lead to oversee global clinical studies, ensuring safety, data quality, and regulatory compliance from start-up to closeout. You will partner with Safety leadership and cross-functional teams to drive execution and risk mitigation across the portfolio.

The role blends clinical research operations, project management, and medical knowledge to guide safety decisions, support regulatory submissions, and advance development

Qualifications

• 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.
• 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.

Skills

Clinical safety leadership

Cross-functional leadership

Project management

Regulatory compliance

Education

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

Advanced clinical degree (MD, PharmD, DNP, NP, PA-C, MSN, PhD, or equivalent)

Job description

Abbott Laboratories in Santa Clara, CA, is seeking a Clinical Safety Program Lead to oversee global clinical studies, ensuring safety, data quality, and regulatory compliance from start-up to closeout. You will partner with Safety leadership and cross-functional teams to drive execution and risk mitigation across the portfolio.

The role blends clinical research operations, project management, and medical knowledge to guide safety decisions, support regulatory submissions, and advance development