Clinical Safety Program Lead
Abbott
Summary
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.
Job description
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.
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 escalate 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 escalate 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.
Requirements
- 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: Advanced clinical degree (MD, PharmD, DNP, NP, PA-C, MSN, PhD, or equivalent).
- Preferred: Medical device, structural heart, vascular, or cardiac rhythm therapeutic area experience.
- Preferred: Experience serving as a Medical Monitor, Safety Lead, or Clinical Safety professional.
- Preferred: PMP certification or advanced project management training.
Benefits
- Medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.