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Associate Director, Clinical Trial Patient Safety
3 months ago
**Company Description**
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. This position is responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing, and continuous improvement efforts. Supports director of CTPS.
**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.
Significant Work Activities:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
**Qualifications**
- Aligns Abbvie principles and values to all areas of work. Bachelor’s degree with related health science background is required (e.g. nursing, pharmacy experience). Advanced degree preferred. 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.
- 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.
- Demonstrated experience in direct management capacity preferred. Significant experience leading cross-functional teams on complex projects. Proven success in results driven process management. 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.
**Additional Information**
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position
