Director, Clinical Process Excellence

Posted 7 Hours Ago
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North Chicago, IL, USA
Hybrid
Senior level
Healthtech • Pharmaceutical
The Role
Lead design and implementation of clinical research processes and change management strategies. Partner with stakeholders to align processes with AbbVies Quality System and GxP regulations, manage CTMS and supporting systems, drive adoption through training and communications, and define metrics for operational excellence in clinical trial execution.
Summary Generated by Built In
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

A sustainable process development and continuous improvement strategy is an integral part of a Quality Management System in GCP governing Research & Development (R&D). The Compliance Learning Change Management (CLCM) organization resides within Clinical Development Operations to sustain an interconnected process and operations ecosystem by seamlessly empowering teams to connect ideas and create meaningful impact.  The Associate Director, Strategic Change Enablement serves as a primary interface between the client and the Compliance Learning Change Management (CLCM) function. Strategic partner with key stakeholders in their areas of focus throughout full lifecycle of strategic initiatives and delivery of solutions – from defining business needs, project planning, development, deployment, change management, and end user adoption – that supports operational excellence in clinical trial execution.  Design clinical research processes and ensure alignment with cross-functional stakeholders.

Responsibilities

  • Responsible for understanding AbbVie's Quality System and Regulations related to GXP activities and the Business Process Framework and is able to translate to stakeholders
  • Thorough understanding of Clinical Trial Management Systems and other associated systems for areas of focus
  • Understand the remit of CLCM in order to leverage their expertise in support of initiative execution
  • Design clinical research processes (e.g. through process mapping and workshops), ensuring alignment with cross-functional stakeholders, and partnering on strategy for implementation, and maintain supporting systems and documentation
  • For functions supporting clinical research, facilitate design of organizational roles and responsibilities, and integrations into AbbVie’s Quality System
  • Develop and deliver on initiative change management strategy, including stakeholder and impact assessments, initiative communications, content development and hosting sessions
  • Manage systems and global program(s) that enable delivery of process & change management
  • Strategic assessment of metrics and measures for their areas of focus

Qualifications

  • BS or BA required; advanced degree preferred
  • 8+ years of experience in pharmaceutical, healthcare or regulated industry preferred.
  • Experience in a leadership role with strong management skills in a complex matrix environment, preferably in the healthcare industry.
  • Demonstration of successful execution of compliance and training strategy in a fast-paced environment managing multiple priorities effectively using innovative and creative solutions.
  • Competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
  • Demonstration of successful coaching/ mentoring, people management and communication skills in a matrix environment.
  • Effective leadership skills with a proven ability to foster global team productivity and cohesiveness.

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 thisposting 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 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 anduntil 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. 

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

Skills Required

  • BS or BA
  • Advanced degree
  • 8+ years experience in pharmaceutical, healthcare, or regulated industry
  • Experience in a leadership role with strong management skills in a complex matrix environment
  • Demonstrated execution of compliance and training strategy managing multiple priorities
  • Competence in SOPs, ICH, global regulations, ethics and compliance
  • Demonstrated coaching, mentoring, people management and communication skills in a matrix environment
  • Thorough understanding of Clinical Trial Management Systems and associated systems

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

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The Company
HQ: North Chicago, IL
50,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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