Associate Director, Clinical Trial Patient Safety

AbbVie; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie is seeking a Clinical Trial Patient Safety leader to oversee world-wide safety data review and ensure timely, compliant reporting. You will coordinate with medical monitors and regulatory teams to drive high-quality safety assessments across studies.

The role focuses on process improvement, SOP development, and staff development within a dynamic CTPS organization, with a strong emphasis on collaboration and data integrity.

Qualifications

• Knowledge of ICH, FDA and EMA regulations affecting drug safety.

Responsibilities

• Oversee world-wide surveillance of clinical trial patient safety data to ensure timely and compliant reporting.
• Establish workload projections and metrics for safety operations.
• Lead staff development and training within the CTPS team.
• Partner with medical monitors to provide oversight of safety reviews at study level.
• Improve SOPs and implement new regulatory requirements.
• Coordinate with clinical, regulatory and pharmacovigilance counterparts.
• Manage 5 to 10 staff and support strategic planning.
• Ensure inspection-ready outputs and effective data review processes.

Job 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.

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.

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html