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Director, Clinical Compliance

Employer
AbbVie
Location
Lake County, IL, US
Start date
Sep 21, 2019

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Discipline
Clinical, Clinical Research, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work
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Job Details

Provides vision, leadership and mentoring to ensure clinical studies are successfully implemented via the foundation of clinical compliance, governing documents and quality control of processes supporting ~2500 employees supporting Development that drives the organization to effectively meet business objectives. Will have both direct and indirect reports.

Key Responsibilities Include:
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Integral contributor to quality governances (e.g., Management Review, R&D Compliance, OEC).
  • Build and maintain high performing functional teams ensuring alignment of individual goals with corporate goals.
  • Meet budget expectations, resource projections and metrics to execute the strategic vision and tactical plans.
  • Partner with Sr. Leadership (VPs & Directors) to ensuring alignment with business objectives and priorities when developing and maintaining standards and compliance strategies.
  • Integral participant during regulatory inspections and process improvement initiatives.
  • This position will be integral in setting the strategy and direct and oversee the foundation of quality and compliance required during the execution of clinical programs, develop, analyze and communicate data that monitors the performance and quality of clinical programs execution.
  • The risk management, decision-making, quality execution are critical to program success and ensuring pipeline decisions can be made on quality data.
  • This position will report into a senior director level. This position will be responsible for functional budgets and resource management as well as identifying areas for potential cost savings.
  • This position is responsible for problem solving, risk mitigation and contingency plans at a global level.


  • Bachelor's Degree or equivalent is required, typically in nursing or scientific field.
  • Must have 12+ years of Pharma-related/ clinical research related experience (and/or applicable work experience); including 8 years (and/or applicable work experience); in clinical research demonstrating a high level of core, technical and leadership competencies through setting and driving strategy and leading a global team.
  • Effective leadership skills with a proven ability to foster team productivity and cohesiveness.
  • Demonstration of successful coaching/ mentoring and people management.
  • Expertise in drug development, operations and resource/ budget planning across global geographies.
  • Demonstration of successful execution of compliance and training strategy in a fast-paced environment managing multiple priorities effectively.

Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
 North Chicago
Illinois
60064
US
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