Clinical Safety Program Lead

RXinsider LTD.; Maple Grove (MN); Hybrid; USD 99,000 - 199,000; Full time

Job summary

Abbott in the United States seeks a Clinical Safety Program Lead to drive global clinical investigations with safety oversight, risk management, and cross-functional leadership across safety, regulatory, and operations.

You will own safety data review, protocol development, and inspection readiness, mentoring teams and ensuring timely, compliant study delivery across the portfolio, while advancing patient safety and scientific integrity.

Qualifications

• Bachelor's degree or higher required in a life sciences field.
• 5+ years of clinical research experience.
• Experience leading global clinical studies and cross-functional teams.
• Strong knowledge of GCP, ISO 14155, FDA regulations and MDR.

Responsibilities

• Lead the operational execution and safety oversight of global clinical studies from start-up through closeout.
• Serve as the primary safety lead for the assigned portfolio, assessing safety data and risks.
• Support operational decision-making by identifying gaps and developing solutions with cross-functional teams.
• Develop study-specific safety management strategies and risk mitigation plans.
• Ensure timely and compliant safety reporting to regulators, investigators and ethics committees.
• Mentor team members and promote collaboration, accountability and continuous improvement.

Skills

Clinical research leadership

Safety oversight

Cross-functional collaboration

Regulatory compliance

GCP/ISO 14155 knowledge

Project management

Communication skills

Education

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

Job description

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.

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.

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 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.

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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives :

www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

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.