Global 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 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.