Director, Epidemiology (Immunology)

GlaxoSmithKline ,
Stevenage, Hertfordshire
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Job Description

This position functions within GlaxoSmithKline's Epidemiology Department, part of R&D Value, Evidence and Outcomes, which contributes to the successful development and commercialization of new therapies and supports a wide range of areas, from Clinical Development and Safety and Effectiveness Evaluation. Our staff in Epidemiology provide leadership and expertise to develop and execute the Epidemiology strategy across the whole spectrum of drug development, from early drug discovery to registration, reimbursement and lifecycle management. As Epidemiology Director you will assume epidemiology responsibility for multiple development compounds and/or marketed medicines within a therapeutic area, developing a program of studies. You will be responsible for planning, implementing and delivering high quality, scientifically robust observational research projects which support drug development programs, regulatory submissions and post marketing safety and effectiveness. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... * As a technical expert in epidemiology and the therapeutic area, maintain and expand an epidemiology support strategy aligned to the drug development strategy and aimed to: * Improve disease understanding relevant to drug development: incidence, prevalence, risk factors, natural history course, treatment patterns, co-morbidities, co-medications, outcome measures, phenotypes, biomarkers, unmet needs, and their variations across domains such as demographics and geographies. * Support and be accountable to advise scientifically on Real World Evidence strategies * Contribute to medication safety evaluation: provide background event rates, synthesize existing evidence including through meta-analyses, identify high-risk populations. * Propose and lead post-marketing activities: risk evaluation mitigation strategies, epidemiology studies for signal detection and inference, post-authorization studies of treatment benefit and risk. * Critically appraise existing epidemiology evidence and create new evidence through delivery of specific research plans/protocols and analysis of healthcare databases available within GSK. * Develop strong partnerships with internal stakeholders in a multi-disciplinary framework (clinical, safety, regulatory, health outcomes, asset leadership) to meet product needs. * Plan resource allocation to accomplish multiple research projects and attain project and study timelines. * Identify innovative, timely and cost effective methods to conduct epidemiologic studies. * Negotiate internal funding of projects. * Develop and negotiate research plans with external collaborators in academia or contract research organizations and work effectively with vendors for outsourced studies. * Communicate study findings to relevant internal and external audiences effectively. * Input into regulatory submission documents and represent the function to regulatory agencies as required * Present the company position on epidemiology issues and epidemiology findings to regulatory agencies and other external authorities. * Extend a track record of external publications in peer reviewed journals in support of asset teams. * Strengthen the position of the Epidemiology group as a recognized leader in the application of epidemiology to Immunology (Immuno-Inflammation) research and development Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * A combination of academic training and practical experience in epidemiology is required. This may consist of: * Doctoral degree (PhD., ScD or DrPH) in epidemiology (preferred) or a relevant discipline (i.e. health services research, health outcomes research, public health, statistics or pharmaceutical sciences) * Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in Epidemiology with at least five years experience leading pharmaco-epidemiologic research in a drug development environment. * Demonstrable experience leading pharmaco-epidemiologic research programs in a drug development environment. * Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings. * Preferred Qualifications: If you have the following characteristics, it would be a plus: * Expertise in epidemiology of immuno-inflammatory conditions * Self motivated with the ability to work independently to develop credibility with colleagues within and outside Epidemiology, as well as interact effectively in multi-disciplinary matrix teams to influence decisions. * Broad experience in collaborating with research partners * Ability to demonstrate strategic thinking and problem resolution to fill evidence gaps. * Ability to work well within a business-driven environment, balance priorities and handle multiple tasks through careful planning, stakeholder

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