The purpose of this position is to provide strategic epidemiology and risk management planning to support company and product-specific strategic objectives. The following are key elements of position objectives:
Develop and execute post-licensure observational studies of vaccine safety and effectiveness for the Dengue Tetravalent Vaccine risk management plans that are related to new product submissions to regulatory agencies worldwide.
Develop epidemiology strategies to support vaccine business unit objectives. Provide expertise in the design, management and evaluation of epidemiology study protocols, clinical trial protocols and signal detection initiatives.
Contribute to the evaluation and estimation of safety risks for all clinical development and marketed products.
Design, conduct and interpret epidemiology studies to support Global Product Strategy Team objectives.
Responsibilities include epidemiology, risk management planning, risk evaluation and mitigation strategy development, signal detection, and analysis of adverse events for clinical development and marketed products.
Design and conduct therapeutic area- or product-specific epidemiology studies in support of the product throughout the life-cycle.
Design and conduct the epidemiological studies for the assigned therapeutic areas and products.
Develop the epidemiology strategies to routinely & properly evaluate and update the product-specific safety profile for each compound in development.
Develop the epidemiology strategies to routinely & properly evaluate and update the product-specific safety profile for each compound on the market.
Develop epidemiology strategies to help achieve product strategic targets and objectives.
Coordinate epidemiology efforts with statistics, clinical development, regulatory affairs, medical affairs and marketing to support each of these function's activities in the relevant therapeutic areas.
Design and conduct epidemiology and signal detection analyses in various databases such as observational clinical databases, observational claims databases and non-denominator adverse event reporting databases for the relevant therapeutic area.
Interpret, evaluate, and respond to, ad hoc requests for safety information from internal and external organizations in coordination with the epidemiology and pharmacovigilance management.
Provide epidemiology expertise in support of due diligence efforts.
Provide epidemiology expertise in support of specific clinical development programs.
Speak at internal and external venues
Represent Takeda at Pharmacoepidemiology meetings, and relevant Regulatory Agency meetings.
Conduct and support the conduct of signal detection and data analysis efforts including integrated safety reviews, periodic (monthly/quarterly, etc) safety and signal tracking reporting for specific compounds for assigned therapeutic areas and products.
Liaise with external safety advisory boards with respect to specific compounds.
EDUCATION, EXPERIENCE AND SKILLS:
Required: Ph.D. (in Epidemiology) or PharmD with a Master's Degree in Epidemiology with 7-10 years experience in the pharmaceutical industry or directly relevant to the responsibilities of the position.
Preferred: MD/MPH with a minimum of 7 years experience in the pharmaceutical industry or directly relevant to the responsibilities of the position.
Ability to follow scientific arguments, identify Pharmacoepidemiology scientific data needs and solve Pharmacoepidemiology issues.
Ability to obtain Pharmacoepidemiology regulatory opinions, assimilate data effectively, define a Pharmacoepidemiology regulatory strategy and communicate with local agencies n meetings as required.
Ability to understand the market and regulatory challenges and to critically review competitors' data.
Ability to form and develop internal and external alliances.
Excellent scientific writing and technical skills.
Excellent team working skills.
Staff management experience.
Proven in-depth knowledge of epidemiologic and statistical modeling, especially in t he observational setting. Understanding of health utilities, clinical decision analysis, and clinical trials is essential.
Experienced in highly complex operational problems, such as study logistics, research prioritization, vendor management and resource needs. The individual must have excellent coordination and team working skills as there will be involvement in multiple clinical research teams and functional areas in US,EU and LATAM.
Must possess an understanding of the dynamics of decision-making. Must have a high degree of creativity and motivation for continued support of diverse scientific disciplines. The individual must be able to make decisions such as endorsing a specific analytical plan, and detail research findings in verbal and scripted form.
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Takeda Pharmaceuticals North America