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VP Clinical Field Operations

Reference Number: 2877
Location: Midwest

Our client is a global, research-based biopharmaceutical company.  They have asked us to assist them in their search for a VP Clinical Field Operations.

The VP Clinical Field Operations oversees a global organization of more than 700 employees/Contractor FTEs operating in over 60 countries with responsibility for the on time, within budget and quality delivery of almost all of the company’s pipeline and Global Medical Affairs clinical studies.

Major tasks and responsibilities will include:

  • Establishes and maintains excellent relationships with investigators and their site staff so that the company is viewed as “Sponsor of Choice”.  For medical therapy areas that the company is entering for the first time, this organization is the “first contact” with these physicians and potential future customers and is therefore accountable for ensuring the company builds and maintains an excellent Sponsor reputation and customer relationships.
  • Will initially lead the organization through a significant expansion over a period of approximately 2 years.  This must be accomplished while meeting project timeline commitments and maintaining compliance and integrity of the clinical data.
  • Provides strategic leadership and direction to the Clinical Field Operations organization consisting of Site Management and Monitoring, Strategic Study Start-Up and Strategic Patient Recruitment, a global organization operating in 60+ countries and with a staff of 570+ employees and contractors and anticipated expansion to over 700 in total.
  • Provides appropriate strategic framework, oversight, reviews and operational flexibility to ensure the on time and on budget delivery of clinical programs which is a top priority as well as a critical success factor in realizing the LRP.  This position is accountable for the within and across country operationalization of worldwide clinical trials with quality and integrity of the data.
  • Requires working in partnership with peer VPs and Executive and Sr. Directors in Pharmaceutical Development and Medical Affairs responsible for the Scientific and Medical aspects of the programs as well as across the company in R&D and other functions, including the affiliate general manager community since the clinical Field operations staff are located within the affiliate offices and count on local affiliate support in many critical functions such as legal, finance, regulatory, PV, human resources and medical affairs.
  • Provides input and strategic direction into planning and processes for determining timelines and budgets for global clinical studies and programs to ensure that plans are able to be executed as per commitments to the corporation.
  • Establishes the optimal strategic geographic operational footprint for clinical Field operations to deliver the studies required by the clinical development plan and in line with the company’s corporate commercial strategy.
  • Ensures appropriate staffing models are implemented to match the geographic footprint and that operations are streamlined and efficient.
  • Provides strategic direction and oversight of resource planning, staffing and management of teams across studies, ongoing resource and budget management, the appropriate use of contract/Functional Service Provider resources.
  • Accountable for long-range resource planning, budgeting and study conduct model/strategy to meet the needs of R&D and drive cost efficiencies in clinical trial conduct.
  • Ensures organization is operating in compliance with ICH GCP Guidelines and local and worldwide regulatory (GCP, Ethics, Financial, Customs, Trade, etc.) requirements.  Keeps up to date on emerging and changing regulations and is a key contributor in determining advocacy positions for the company as well as its approach to compliance.
  • Runs the organization like a business.  Provides strategic direction and drives continuous improvement in organizational performance by keeping an up to date knowledge of industry and future trends, using innovative approaches and Key Performance Indicators (KPIs) and benchmarking to drive to achieve world class clinical execution.  Ensures Field Operations is efficient and cost effective versus alternative models.
  • Responsible for people growth and development within the Clinical Operations global organization.

We seek candidates with the following qualifications:

  • 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.  A diversity of experience across a broad spectrum of Clinical Operations activities is preferred.
  • 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.
  • 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”.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2877. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.