Vice President of Clinical Operations

Our client, a growing and dynamic pharmaceutical company with revenues in excess of $100 million is experiencing tremendous success and is seeking an experienced Vice president of Development Operations to join their executive management team.This company is highly entrepreneurial with a positive P & L, has a growing portfolio of product and pipeline opportunities in various clinical trial phases and has a successful product currently on the market in great demand.
Key responsibilities are to provide leadership, functionally and managerially, within the Development Operations and Project Management Organization.
The successful candidate will be responsible for the planning, direction, execution, and interpretation of clinical research and trials and related project management issues.Included will be the establishment of scientific methodology, protocol design and the execution of sound and focused clinical studies, data collection, data management and analysis to ensure the successful filings and approval of IND’s and NDA’s.
The Vice President of Development Operations will provide expert medical and scientific advice to senior management in evaluation of all clinical operations, project goals and scope and ongoing interpretation of project findings.
RESPONSIBILITIES:Direct the design and implementation of all clinical operations including protocol review, clinical site selection, conduct of trials data accumulation and interpretation.Provides administrative and technical direction in support of all Clinical Projects.Ensures quality of clinical plans, project specifications, study protocols, reports, and publications for all company projects.Analyze company goals in relation to new and ongoing projects to assure balance between new and ongoing programs, inclusive of budget and resource management.Facilitate project and product development teams by determining project team composition and preparing organizational charts; evaluation of appropriate sources for project information and dissemination of information as appropriate to relevant employees and outside partners; analysis of information in order to prepare and update project plan time lines; assessing project activity, identifying and resolving potential project complications; and facilitating complex problem solving and consensus building.Serves as a key contact person for industrial or academic partners and collaborators on project related issues.
REQUIREMENTS
The successful candidate will demonstrate a past history of solid clinical trial management with regard to all aspects of operations and clinical trial logistics. Individual will manage, train, develop and lead cross-functional teams (i.e. clinical teams, study management teams, process-system initiatives) and/or departmental groups. Critical to the position, is the ability to work within a fast changing, and time sensitive environment.EDUCATIONAL & PREQUISITE REQUIREMENTS:Prior exposure to Development Operations and Project Management demonstrated through at least five to ten years of Pharmaceutical Industry experience and experience managing clinical programs.Excellent communication and presentation skills required plus the ability to function in a multi-tasking matrix environment.Knowledge of and prior exposure to regulatory requirements and agencies is important.