Associate Director, Clinical Trial Patient Safety

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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.

Qualifications

• Bachelor’s degree in a healthcare discipline (i.e. Life Science, Pharmacy, Nursing or healthcare profession, or biomedical disciplines). Graduate degree preferred. 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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