Clinical Safety Program Lead

Abbott (abbottcareers2 board); Santa Clara (CA); Vor Ort; USD 160.000 - 230.000; Vollzeit

Benefits dieser Stelle

HIP PPO medical plan

Strong retirement contributions

Tuition reimbursement

Zusammenfassung

Abbott is seeking a Clinical Safety Program Lead to oversee global clinical studies with a focus on safety, data integrity, and regulatory compliance. Partner with Safety leadership to deliver studies efficiently while maintaining subject safety and quality.

Lead end-to-end safety processes and cross-functional risk mitigation across the portfolio. The role emphasizes inspection-ready data, protocol development, and collaboration with Clinical Operations, Regulatory Affairs, and Biostatistics to

Qualifikationen

• Lead global clinical studies with safety oversight and operational leadership.
• Collaborate across Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics and Data Management.

Aufgaben

• Lead the operational execution and safety oversight of global clinical studies from start-up through closeout.
• Serve as primary safety lead for assigned portfolio with expert assessment of safety data and risks.
• Support operational decision-making by identifying gaps and developing solutions across cross-functional teams.
• Develop and implement study-specific safety management strategies and risk mitigation plans.
• Ensure timely safety reporting to regulatory authorities and stakeholders.
• Mentor team members and drive a culture of collaboration and continuous improvement.

Jobbeschreibung

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

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.

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 escalated 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 escalated risk to leadership.
• Maintain awareness of emerging clinical evidence, disease-state developments, and competitive technologies.
• Establish and drive study timelines, deliverables, and action plans while holding teams accou