Senior Manager, Epidemiology (Immunology)

GlaxoSmithKline ,
Stevenage, Hertfordshire
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Overview

Job Description

Would you like to be part of GSK's emerging clinical leadership, with an opportunity to drive evidence strategy and planning for our clinical programs? If so, this could be an excellent opportunity to explore. As an Epidemiology Manager within GlaxoSmithKline's Epidemiology Department, part of R&D Value, Evidence and Outcomes, you will contribute 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 an Epidemiology Manager you will support the epidemiology program for multiple development compounds and/or marketed medicines within the Oncology 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 oncology 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 * Extend a track record of external publications in peer reviewed journals in support of immunology (immuno-inflammation) asset teams. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Master's degree in Epidemiology or relevant discipline (i.e. health services research, health outcomes research, public health, statistics or pharmaceutical sciences) * 2 or more years of experience conducting epidemiological research * 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: * Doctoral degree (PhD., ScD or DrPH) in Epidemiology or related field strongly preferred * Pharmaco-epidemiology industry or academic experience * Expertise in epidemiology of immunology (immuno-inflammation) diseases * Record of high-quality, peer-reviewed epidemiology and/or outcomes research publications * 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 * 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 management, project administration, and organisational skills * Record of high-quality, peer-reviewed epidemiology and/or outcomes research publications and/or demonstrated leadership in external scientific s

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