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VP of Clinical Program Development

Reference Number: 2876
Location: Midwest

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

The VP of Clinical Program Development oversees a global organization of more than 400 employees/contractors and is accountable for the operational design and delivery of all Therapeutic Area clinical programs in the Development Pipeline & for Medical Affairs on Market Product Clinical Programs in over 60 countries.

Major tasks and responsibilities will include:

  • Operational design of clinical programs and studies.
  • Clinical program and study planning via the Clinical Strategy Team in partnership with the Medical Director and as leaders of the Clinical Study Team with the Study designated Physician.  Includes study design and conduct, timelines and budgets.
  • Oversight and management of each clinical program & study execution across multiple Functions to achieve timelines and budgets and in compliance with relevant worldwide Regulatory requirements.
  • Ensures compliance with study design and scientific and medical objectives, oversight of data acquisition and integrity in partnership with the study physicians.
  • Key contributor to medical and scientific documents for clinical trials as well as documents for global Regulatory submissions.
  • Provides strategic leadership and direction to the Clinical Program Development, a global organization operating clinical studies in 60+ countries and with a staff of 400+ employees and contractors in multiple countries around the world.
  • Establishes an appropriate framework and oversight including input into prioritization, reviews and decision making to maximize the probability of achieving 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.
  • Accountable for the on time and on budget operational delivery of all of the company’s worldwide clinical trials with quality and integrity of the data including both Development and Medical Affairs trials.
  • Requires working in partnership with peer VPs, Executive and Sr. Directors in Pharmaceutical Development, Medical Affairs responsible for the Scientific and Medical aspects of the programs and across the company.  The VP will also work in close collaboration with peer VPs and Senior Directors in other functions to ensure organizational resource alignment to achieve delivery of all committed clinical timelines across the portfolio of workload.
  • Accountable for appropriate planning of study timelines and budgets and for ensuring that planned programs can be executed within the delivery committed to the corporation within committed budgets and with acceptable data quality.
  • Directly manages the Clinical Operations Therapeutic Area Lead Directors.
  • Ensures the recruitment and development of the right talent and therapeutic area expertise to enable the appropriate level of input into clinical program design and clinical study design as well as operational expertise and the right level of support to the Asset Development Teams, Clinical Strategy Teams and leadership of the Clinical Study Teams.
  • Accountable for ensuring the right level of staffing and resource availability and expertise to meet delivery commitments.
  • Develops and implements strategic vendor selection and management/oversight program for the wide range of vendors that are used in clinical development.  Accountable for resolving vendor issues that need to be addressed at the executive level.
  • Maintains an up to date industry knowledge in therapeutic area clinical development and operationalization of clinical trials.  Participates in Industry leading groups to advocate the company’s position and drive industry level change in the conduct of clinical trials.
  • Drives continual improvement in Clinical Program Development practices, processes and performance to achieve World Class Clinical Execution and driving transformational change to take and keep the company ahead of the competition.
  • 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 including experience in Clinical Program Development in multiple therapeutic areas, in leading large functions and a diversity of experience across the scope of Clinical Operations activities.
  • Bachelor’s Degree or higher preferably in a life science discipline.
  • Broad knowledge of Drug Development and on market Medical Affairs.
  • 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 2876. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.