Associate Director, Clinical Trial Patient Safety

🕒 6 days ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $141.5k - $268.5k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• 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

• 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

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