Associate Director, Clinical Trial Patient Safety

Purpose:

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.

Responsibilities:

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.

Core Job Responsibilities include:

• 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.