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Director, Pharmacoepidemiology - Takeda Pharmaceuticals North America
Jun 12
Location: Deerfield, ILCategories: Director
Website: http://www.tpna.com/positions.asp#top
Position Description
Takeda Pharmaceuticals North America has built a solid foundation on successful products, principles, people, and research. We currently have the following position available in Deerfield, IL:
Director, Pharmacoepidemiology
RESPONSIBILITIES:
•Provide support to and work with TGRD development and functional teams by devising and proposing epidemiology studies to meet product needs. This support will span all development stages. These activities should consider and be in support of one or all of the following objectives: clinical, regulatory and marketing.
•The position in TGRD pharmacovigilance will provide support for estimation of safety risks, based on epidemiology data and techniques, for all products in development as well as marketed products. In addition, responsibilities include the design, conduct (as needed) and interpretation of the epidemiology studies in support of and working with the GPSTs.
•The scope of responsibilities includes epidemiology, signal detection, analysis of adverse events for clinical studies and postmarketing and risk management plans.
•Oversee/lead TGRD (EU and US) activities of Pharmacoepidemiology working within the GPST structure.
•Oversee/lead Global Pharmacoepidemiological efforts, including support of TPC’s pharmacoepidemiological needs.
•Responsible for identifying comprehensive Pharmacoepidemiology strategies to help achieve product strategic targets and objectives (includes clinical, regulatory and marketing reimbursement/pricing objectives).
•Responsible for designing Pharmacoepidemiology non-interventional studies (i.e. observational studies and database studies), working with and within the GPSTs. Responsible for the execution of such studies working with clinical teams.
•Internal and external spokesperson and technical expert on Pharmacoepidemiology. Present pharmacoepidemiology data and evidence to regulatory agencies and advisors/opinion leaders.
•Works with Clinical Science in creation and conduct of risk management strategies utilizing epidemiology research techniques.
•Provides epidemiology expertise during due diligence.
•Represents, Takeda at Pharmacoepidemiology meetings, and relevant Regulatory Agency meetings.
•Oversees the Pharmacovigilance plan for the RMP.
•Oversees the signal detection and data analysis associated with safety.
•Sets goals, supervises, and evaluates performance of staff as well as plans growth of personnel.
QUALIFICATIONS:
•Ph.D. (in Epidemiology) or Pharm.D. with a masters in Epidemiology. A MD with a MPH ideal.
•A total of 10 + years experience in the pharmaceutical industry or CRO directly relevant to the responsibilities of the position are required. A minimum of 5 years must be in the pharmaceutical industry.
•Ability to follow scientific arguments, identify Pharmacoepidemiology scientific data needs and solve Pharmacoepidemiology issues as required
•Ability to obtain Pharmacoepidemiology regulatory opinions, assimilate data effectively define an Pharmacoepidemiology regulatory strategy and communicate with FDA in meetings as required.
•Ability to understand the market and regulatory challenges for Takeda products; and to critically review competitors’ data and assimilate Pharmacoepidemiology strategies that take such environments into consideration.
•Excellent scientific writing, technical skills.
•Excellent team working skills.
•Staff management experience.
