VP, Site Management and Monitoring

Employer
AbbVie
Location
Lake County, IL, US
Posted
Jul 09, 2019
Ref
1902592
Required Education
Bachelors Degree
Position Type
Full time
Purpose

The VP Site Management and Monitoring (SMM) oversees a global organization of more than 1300 employees/Contractor operating in over 60 countries with responsibility for the on time, within budget and quality delivery of AbbVie's pipeline [a small number of studies will be outsourced to CROs] in an operationally excellent and world class manner.

Responsibilities
  • Provides strategic leadership and direction to global SMM consisting of the site management and monitoring organization, contract management outside the US, and centralized site monitor data reviewers to ensure the on time and within budget delivery of clinical programs, regulatory submissions, and successful regulatory inspections across all therapeutic areas.
  • Provides appropriate strategic framework, oversight, and operational flexibility to ensure the on time and on budget delivery of clinical programs which is an AbbVie top priority and CEO imperative as well as a critical success factor in realizing the LRP; This position is accountable for operationalization and execution of worldwide clinical trials within and across countries while ensuring quality and integrity of the data.
  • Works in partnership with peer senior leaders in Development, Medical Affairs and other functions across R&D and the broader company; and with the affiliate Medical Director and General Manager One R&D Community to ensure successful delivery of the SMM strategy. • Establishes the optimal geographic operational footprint for SMM to deliver the studies required by the clinical development plan and in line with AbbVie corporate strategy.
  • Provides strategic direction into the planning for determining timelines and budgets for global clinical studies; as well as into the short- and long-range resource planning/models, staffing, and budgeting to meet the needs of Development.
  • Manages the organization like a business. Accountable for driving continuous improvement to achieve global operational excellence and cost-effective clinical trials compared to alternative models;
  • Maintains an up to date knowledge of current industry practices and future trends, as well as global regulations and requirements governing the clinical trial business; Participates in industry leading groups, such as Linking Leaders, and other external leadership forums to advocate AbbVie's position and drive industry level change in the conduct of clinical trials; Ensures that AbbVie is on the forefront of driving the change.
  • Ensures organization is operating in compliance with ICH GCP Guidelines, AbbVie Quality System and local and worldwide regulatory (GCP, Ethics, Financial, Customs, Trade etc) requirements
  • Provides strategic direction and ensures oversight and operational excellence of the global contract management organization; Works in partnership with Legal, Outsourcing, affiliate Finance to ensure that contracting is not on the critical path for startup of clinical trials.
  • Provides strategic direction and ensures oversight and operational excellence of the centralized monitor data reviewer organization; Works in partnership with key stakeholders, include site monitoring, Clinical, Safety, and Data Sciences, within the centralized data review framework, processes and systems, to ensure, in part, patient safety and integrity of data at investigator sites
  • Responsible for people growth and development within own organization, as well as the broader Development Operations organization.


  • A minimum of 15 years of practical clinical development experience in the Pharma Industry. Ideally has significant experience in leading a large Site Management & Monitoring organization such as in a CRO, but CRO experience is not essential. It is, but not required, to have a diversity of experience across a broad spectrum of Clinical Operations activities.
  • Bachelor's Degree or higher, preferably in a life science discipline
  • Thorough knowledge of the clinical drug development process and on market Medical Affairs , and experience in all phases of clinical studies.
  • High level of competency in the AbbVie leadership behaviors.
  • Big picture and strategic thinker - can formulate a vision of future state and lead the organization to build tactical plans to achieve this.
  • Excellent collaborator - easily builds relationships and gains cross functional alignment.
  • Excellent business and financial aptitude, very analytical and uses data to drive the business and continuous improvements.
  • Articulate communicator with "Executive Presence"