Associate Director, Clinical Trial Patient Safety

AbbVie

. Support the Clinical Trial Patient Safety organization in evaluating and ensuring the quality of clinical trial patient safety data .

Posted 9/25/2026full-timeRemote • Illinois • United StatesSenior💰 $141,500 - $268,500 per yearWebsite

About the role

Key responsibilities & impact

Support the Clinical Trial Patient Safety organization in evaluating and ensuring the quality of clinical trial patient safety data
Lead worldwide surveillance of clinical trial patient safety data, including organization, resourcing, and continuous improvement
Manage assigned operational areas, compound-associated clinical studies, and related systems to ensure compliant and timely adverse event surveillance
Establish, monitor, evaluate, and communicate workload projections and operational metrics
Support training programs, knowledge attainment, and staff development
Create and sustain an environment that attracts, develops, and retains scientific professionals
Plan and conduct talent management
Assist with strategic planning and department development
Develop and participate in special projects and CTPS initiatives
Apply ICH, FDA, and EMA regulations and guidelines to drug safety responsibilities and global reporting requirements
Partner with therapeutic-area physicians and medical monitors to oversee medical safety review at the compound-study level
Oversee safety reports, IRB/IEC safety issues, narratives, issue management, document management systems, and centralized data review
Communicate and escalate relevant study and team information to clinical team members and management
Understand, implement, and improve department SOPs and new regulatory requirements
Maintain communication channels with clinical, medical, regulatory, compliance, and pharmacovigilance counterparts
Manage 5 to 10 people

Requirements

What you’ll need

Bachelor's degree in a healthcare discipline, such as Life Science, Pharmacy, Nursing, healthcare profession, or biomedical disciplines
Graduate degree preferred
10 years of experience in clinical research in the pharmaceutical industry
Project management experience with cross-functional projects
Knowledge of the drug development process, including clinical trial conduct, scientific strategy, operations management, regulatory submission requirements, product launch, and post-marketing support
Experience in clinical operations management, clinical study management, drug development, risk management, and/or drug safety operations
Understanding of tools, standards, and approaches to efficiently evaluate drug safety
Experience working in a multidisciplinary, matrix team environment and managing change
Effective leadership and communication skills, including communicating project objectives, issues, risks, and other project information
Sound judgment in managing conflict and negotiations constructively and developing effective working relationships

Benefits

Comp & perks

Paid time off (vacation, holidays, sick)
Medical, dental, and vision insurance
401(k)
Eligibility to participate in long-term incentive programs