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 . 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.

This role can be remote within the US. 

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

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. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-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. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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