Clinical Safety Program Lead

Abbott (abbottcareers2 board); Maple Grove (MN); On-site; USD 150,000 - 180,000; Full time

Job summary

Abbott is seeking a Clinical Safety Program Lead to combine clinical study leadership with project management and medical safety oversight. You will drive global investigations, ensure data quality, and maintain regulatory compliance across the portfolio.

The role requires a blend of operational excellence, safety expertise, and collaboration with Safety leadership to deliver inspection-ready results and strategic guidance throughout the clinical development lifecycle.

Qualifications

• Experience leading clinical research operations with safety oversight.
• Strong project management and cross-functional collaboration skills.
• Clinical or medical knowledge enabling strategic safety leadership.

Responsibilities

• Lead the operational execution and safety oversight of global clinical studies from start-up through closeout.
• Serve as primary safety lead, assessing safety data and emerging risks.
• Support decision-making by identifying gaps and driving solutions with cross-functional teams.
• Develop study-specific safety management strategies and risk mitigation plans.
• Oversee end-to-end data review and quality initiatives to ensure inspection-ready data.
• Collaborate with Regulatory Affairs, Medical Affairs, Biostatistics, and more for study success.
• Drive protocol development, study design, endpoints, and safety monitoring approaches.
• Ensure timely safety reporting to regulators, investigators, and ethics committees.

Skills

Clinical study leadership

Project management

Safety oversight

Cross-functional collaboration

Mentoring

Job description

Working at Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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.

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 escalati 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 escalates 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 accou