Associate Director, Clinical Trial Patient Safety

AbbVie•North Chicago, IL

10d•$141,500 - $268,500

About The Position

This position supports the Clinical Trial Patient Safety (CTPS) organization to achieve its mission of evaluating and ensuring the quality of clinical trial patient safety data by consistent and accurate delivery of high-quality, relevant and timely data review. To create a culture of process improvement, employee development, performance measures, project prioritization, and to develop/implement successful solutions leading the CTPS team, translating the business vision into broad and actionable strategies.

Requirements

Bachelor’s degree in a healthcare discipline (i.e. Life Science, Pharmacy, Nursing or healthcare profession, or biomedical disciplines).
10 years of experience in clinical research in the pharmaceutical industry.
Project management experience with cross-functional projects.
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.
Experience in one or more of the following areas: clinical operations management, clinical study management, drug development, risk management, and/or drug safety operations.
Understanding tools, standards and approaches to efficiently evaluate drug safety.
Demonstrated effectiveness in working in a multidisciplinary, matrix team environment with the ability to manage change.
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.
Demonstrated sound judgment to manage conflict and negotiations constructively and develop effective working relationships to enable high performing teams.

Nice To Haves

Graduate degree preferred.

Responsibilities

Manages assigned operational area(s) compound associated clinical studies and related systems to ensure clinical safety adverse event surveillance is managed in a compliant and timely manner meeting quality outputs within an inspection-ready environment.
Establish, monitor, evaluate, and communicate workload projections and metrics for operational area(s).
Supports department and divisional training programs, ongoing knowledge attainment, and development of staff by effectively identifying department and division needs and successfully presenting them to management.
Creates and sustains an environment that attracts, develops, and retains talented scientific professionals. Plans and conducts active talent management.
Assist management with strategic planning and department development. Develop and participate in special projects for respective teams or CTPS initiatives.
Applies advanced knowledge of ICH, FDA, EMA regulations and guidelines affecting drug safety issues to assigned responsibilities as they impact on CTPS processes, procedures, and global reporting requirements.
Partner with therapeutic area MDs/medical monitors to provide oversight of medical safety review at the compound study level, including ad-hoc safety reports, IRB/IEC safety issues, narratives, etc.
Provide oversight of narrative deliverables, issue management, document management systems, and centralized data review for assigned compound associated clinical studies. Effectively communicates/escalates relevant study and/or team-related information to appropriate clinical team members and/or management.
Understands, implements and improves department SOPs as part of continuous improvement, including implementation of new regulatory requirements.
Aligns and maintains effective communication channels with key clinical, medical, study team, including regulatory, compliance, and pharmacovigilance counterparts. Provides perspective, insight and benchmark information and approaches for business-related initiatives.
Manages 5 to 10 people.