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Director, Epidemiology

Reference Number: 3017
Location: Midwest

Our client is a global, research-based biopharmaceutical company.  They have asked us to assist them in their search for a Director, Epidemiology.

The Director, Epidemiology provides project leadership for a team of professionals, including project managers who deal with various aspects of epidemiology knowledge and skills as well as data management professionals. The incumbent reports directly to the Senior Director/Head of Global Surveillance and Pharmacoepidemiology.

Major tasks and responsibilities will include:

  • Accountable to the Senior Director/Head of Global Surveillance and Pharmacoepidemiology for reporting of new or relevant information concerning industry pharmacoepidemiology knowledge and methods and safety issues.
  • Responsible and accountable for input regarding the design, analysis, and interpretation of pharmacoepidemiology studies.
  • Responsible for participating in cross functional teams who assemble and interpret adverse event data from multiple sources.
  • Maintains a thorough knowledge of epidemiologic methods and data resources as well as applications for their use.  Provides an in-depth understanding and knowledge of epidemiology principles which may be utilized in the analysis of observational data.  Provides project leadership for the development and implementation of epidemiology methods and technology used in the assessment of risk.
  • Provides senior level epidemiological input into establishing GSP standards, processes and policies for the use of observational/epidemiological data.
  • Provides expert level consultation on epidemiological issues to a variety of stakeholders across the Company.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Contributes to the strategy, vision and high-level processes for producing high-quality pharmacoepidemiologic assessments by contributing to the development and implementation of a comprehensive pharmacoepidemiology program to maximize efficiency and success of safety analysis.
  • Directs the development, writing, and maintaining of policies and procedures that establish the standards for using epidemiology to understand/evaluate drugs safety.
  • Maintains awareness of U.S. and international laws and regulations governing the evaluation of drugs safety, keeping abreast of current changes that may involve epidemiology.
  • Consults and provides guidance on epidemiologic methods for departments requesting such input.
  • Maintains "state-of-the-art" knowledge of design and analysis of pharmacoepidemiology assessments.
  • Identifies study groups/data sources which are both time and cost-efficient and appropriate for the research question being investigated.
  • Evaluates study results and insuring quality of epidemiologic studies as well as data generated within Global Medical Services.  Identifies and discusses biases, which may impact the interpretation of the data.
  • Monitors epidemiology studies to ensure appropriate methods are being used, including formulating hypothesis, study design, analysis, and report writing.
  • Provides Formal Critical Appraisal of Observational Studies and Observational Study protocols.
  • Provides interpretation of data from patient registries as well as giving input on registry design.
  • Interacts with other Global Medical Services groups who are responsible for safety evaluations to produce a quality analysis document for regulatory or scientific purposes.

We seek candidates with the following qualifications:

  • PhD in epidemiology or MD/MPH or MD/PhD in epidemiology with minimum of 5 years applied epidemiology experience.
  • 8 years in regulated pharmaceutical industry including: 5-7 years within a drug safety environment and 4-5 years in Epidemiology.
  • Experience in observational/population based databases preferred.
  • Experience in drug safety preferred.
  • Knows how businesses work; knowledgeable in current and possible future polices, practices, trends, developments in information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
  • Is good at establishing clear directions; sets stretching objectives; maintains two-way dialogue with others on work and results; brings out the best in people; is a clear communicator.
  • Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
  • Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
  • Creates strong morale and spirit in his/her team; shares wins and successes; fosters open dialogue.
  • Knows the financial implications of decisions regarding data, capital expenses and vendor agreements.
  • Sets priorities to efficiently accomplish goals.
  • Understanding of epidemiology principles and practices for application to industry issues.
  • Clinical knowledge to apply to the adverse event process, strategy development, case review and approval; understanding of pharmaceutical research and development and its impact on Pharmacovigilance; knowledge of epidemiologic principles to analytic process.
  • Significant knowledge of quality assurance, global regulations, legal and regulatory functions.
  • Knowledge of data base functionalities and management processes.
  • A high-level understanding of U.S. and international safety regulations and current regulatory safety review processes.

 

 

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 3017. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.