Associate Director, Safety Data Architect

Summary

Join AbbVie's Clinical Trial Patient Safety team as a Safety Data Architect, working collaboratively with colleagues across the product lifecycle to ensure patient safety worldwide. You will be responsible for summarizing potential safety concerns from clinical trial data, driving consistency across protocols, and contributing to regulatory responses. This role requires a Bachelor's degree in a healthcare discipline and 10 years of clinical research experience in the pharmaceutical industry. The position offers opportunities for remote work within the United States and includes a comprehensive benefits package.

Requirements

• Have a Bachelor’s degree in a healthcare discipline (i.e. Life Science, Pharmacy, Nursing or healthcare profession, or biomedical disciplines)
• Have 10 years of experience in clinical research in the pharmaceutical industry
• Have project management experience with cross-functional projects
• Have knowledge of the drug development process which includes clinical trial conduct, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support
• Have experience in one or more of the following areas: clinical operations management, clinical study management, drug development, risk management, and/or drug safety operations
• Have understanding of tools, standards and approaches to efficiently evaluate drug safety
• Demonstrate effectiveness in working in a multidisciplinary, matrix team environment with the ability to manage change
• Possess leadership and communication skills that minimally include: effective and timely communication of project objectives, issues/risks and other project information required to keep the team and management informed
• Demonstrate sound judgment to manage conflict and negotiations constructively and develop effective working relationships to enable high performing teams

Responsibilities

• Function as a driver for data in aggregate to enhance presentation of, or delivery of compound safety within PPS and Clinical Teams
• Be instrumental in coordination of deliverables and meetings to review data in aggregate with the PST Leads and PST TA physicians
• Proactively utilize clinical experience and medical knowledge to support the PST Lead and PST TA physician, identifying potential safety concerns from clinical trial data
• Ensure consistent safety perspective in study protocols, annual reports, and act as a key driver of updates to Investigator Brochures, Safety Monitoring Plans, and other ad hoc safety reports, as applicable
• Review for consistency across an assigned compound(s) and indication(s) for safety risk language, AESIs (adverse events of special interest), frequency of data in aggregate review, through contributions to the safety monitoring plan
• In partnership with PST Lead, PST TA physician, and PST PM support contribution of clinical trial data to regulatory response
• As a strong communicator, ensure alignment, consistency, and data integrity for assigned safety activities. Proactively promote best practice and knowledge sharing between the PST lead and the PST TA physician to facilitate scientific based discussions and safety decision making
• Demonstrate ability to connect regulatory obligations and safety science to support safety decision making
• Manage direct reports

Preferred Qualifications

Have a Graduate degree

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs
• Remote work in the United States