Associate Director, Epidemiology Bacterial Vaccines

Reference #: 402942 Site Name: Collegeville TSA, Belgium-Wavre, Canada - Ontario - Mississauga, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham Posted Date: Aug 20 2024 Would you like to be part of GSK's Global Epidemiology, Vaccines team, with an opportunity to drive Epidemiology strategy and studies across the spectrum of vaccine development? If so, this is an excellent opportunity to explore. Job Purpose The Associate Director in Epidemiology will support epidemiological strategy for programs led by the Epidemiology Cluster Head- Bacterial vaccines. The goal is to ensure high quality and on-time delivery of epidemiology data that will allow and support world-wide registration in compliance with the epidemiology plan, applicable good practices, and non-interventional studies standard operating procedures (SOP). As an Associate Director in Epidemiology, you will provide scientific leadership in the application of epidemiological expertise and methods to address key challenges identified across all phases of vaccine development for an asset or disease area to deliver new vaccines more efficiently and effectively to patients. This position functions in the Epidemiology department, within the organization of the Chief Medical Officer, R&D; which contributes to the successful development of new vaccines. Our staff in Epidemiology provide leadership and expertise to develop and execute the Epidemiology strategy across the entire spectrum of vaccine development, from early discovery to registration and lifecycle management. Key responsibility 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 disease area, maintain and expand an epidemiology plan aligned to the vaccine development strategy. Improve disease understanding relevant to vaccine development: incidence, prevalence, risk factors, natural history course, treatment patterns, co-morbidities, co-medications/vaccinations, outcome measures, serotypes, 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 vaccine safety evaluation: provide background event rates, synthesize existing evidence including through meta-analyses, identify high-risk populations. Propose and lead post-marketing activities: epidemiology studies for safety surveillance and inference, post-authorization studies supporting the benefit/risk evaluation. 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 and other functions) 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 bacterial vaccines research and development. Why yo ? Basic Qualifications: 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 master-degree in Epidemiology with experience leading pharmaco-epidemiologic research in a vaccine development environment. Experience leading pharmaco-epidemiologic research programs in a vaccine development environment. Expertise in infectious disease epidemiology and research, including disease causative agent, disease acquisition, transmission, and progression aspects; and vaccines. Preferred Qualifications: Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings. Good knowledge on colonization aspects and antimicrobial susceptibility/resistance (AMR) towards bacterial infections. Identifying target populations with disease burden and epidemiologic and demographic characteristics to support vaccine development strategy. 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. Problem-solver; ability to see solutions to complex, unique situations where the epidemiological principles need to be applied. Ability to work well within a global and matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills. Ability to relay complex, technical information from real world studies to cross-functional teams, stakeholders, and non-technical audiences. Record of high-quality, peer-reviewed epidemiology and/or outcomes research publications and/or demonstrated leadership in external scientific societies/industry-wide collaboration. Excellent understanding of the pharmaceutical industry environment across multiple countries/regions Experience in leading epidemiology research in US, EU, and Asia-Pacific Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor, and risk. Managing individual performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Supporting budgeting and forecasting, commercial and financial acumen. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where p

Created: 2024-11-02