AbbVie

Director, Clinical Systems Design

Employer
AbbVie
Location
Madison, New Jersey
Posted
Oct 08, 2021
Ref
2108199
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Introduction:

The Director, Clinical Systems Design, provides leadership for the design and development of fit-for-purpose clinical data collection systems such as Electronic Data Capture (EDC) across all therapeutic areas. This role is key to ensuring successful delivery against the assigned program- and study-level clinical systems accountabilities. AbbVie’s Clinical Data Strategy & Operations team focuses on bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. The Director is accountable for understanding the demand of the business as well as changing need of the clinical development organization and implementing user-centric designs in key clinical data collection systems.

 

Responsibilities:

  • Understands changing business needs of emerging and adaptive clinical study designs and provides fit-for-purpose data collection tools and technologies to effectively capture data from the clinical sites and patients. 
  • Sources and implements new technology to meet business needs, in keeping with industry best practice. Works with Clinical Data and Technology leadership to identify emerging technology.
  • Uses robust processes to identify fit-for-purpose vendors that can best position clinical development for success. Works with vendors to ensure that highest quality services and technologies are delivered.
  • Manages relationships with all global project teams, understanding their needs and assuring that solutions meet stringent quality standards and are developed expeditiously.
  • Ensures that global processes/procedures are established that meet regulatory standards and requirements per GCP.
  • Leads one or more technology areas within Clinical Technology Strategy & Operations. Understands the flow across all technology and operational areas and works with other leaders and staff to continuously improve operations.
  • Ensures that staff maintain high-quality documentation required by procedures and that those documentation are readily accessible to support inspection requests.
  • Guides partner organizations through change management as appropriate
  • Allocate global resources to maximize efficiencies. Recruit and develop individuals to maximize the collective skills of the organization and to groom future leaders. Provide coaching and direction to further enhance capabilities and performance. Lead and develop direct reports to plan, schedule, and monitor work to ensure all project objectives are met.

Qualifications
  • Minimum of a Bachelor’s Degree is required
  • 10+ years’ experience in clinical development in pharmaceutical or related industry
  • 5+ years managing matrixed and/or direct reports.
  • Expert-level knowledge of clinical development technology and process
  • Skilled personnel and staff developer
  • Skilled problem solver
  • Excellent written and verbal communication
  • Skilled at negotiation and conflict management
  • Expert-level stakeholder relationship manager
  • Experience leading large-scale technology initiatives.
  • Experience leading clinical trial process development initiatives

Significant Work Activities
N/A
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.