Associate Director, Medical Safety Surveillance

Summary

Join AbbVie's Clinical Trial Patient Safety (CTPS) organization as a manager overseeing worldwide clinical trial patient safety data surveillance. You will manage a team of 5-10 people, ensuring compliant and timely data review within an inspection-ready environment. Responsibilities include workload projection, staff development, strategic planning, and collaboration with medical teams. This role requires a Bachelor's degree in a health science field, 10+ years of experience (including clinical practice and drug safety), and expertise in relevant regulations. The position offers remote work within the US and a comprehensive benefits package including paid time off, health insurance, and participation in short-term and long-term incentive programs.

Requirements

• Bachelor’s degree with related health science background is required (e.g. nursing, pharmacy experience)
• A minimum of 10 years’experience to include at least 3 years of clinical practice experience and 3 years drug safety experience with clinical trial life cycle management –Pre-clinical to Phase III through launch to market
• Aligns to Abbvie principles and values to all areas of work
• Demonstrates the willingness to make and accept unpopular decisions or take opposing positions
• Frequently initiates review of current processes and searches for innovative solutions. Challenges status quo or traditional way of operating. Consistently utilizes creativity and original thinking throughout all problem-solving processes
• Subject matter expertise in industry regulations, processes, and clinical safety
• Computer proficient (Windows, Word, Excel) and proficient in use of databases (e.g., oracle/clinical, PIMS, laboratory databases)
• Accurately and medically sound presentation of safety data, both orally and in writing
• Is a strategic thinker. Demonstrates ability to establish clear directions, sets stretch objectives
• Demonstrates excellent interpersonal, leadership, communication and development skills. Able to give and receive constructive feedback
• Strong influencing skills. Ability to manage complex issues and distill information
• In depth understanding of product safety profile including labeling, literature, clinical and regulatory issues

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

Preferred Qualifications

• Advanced degree preferred
• Demonstrated experience in direct management capacity preferred
• Significant experience leading cross-functional teams on complex projects. Proven success in results driven process management

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs
• This role can be remote within the United States