Site Name: Upper Providence, Belgium-Wavre, Mississauga, 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 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 a Director in Epidemiology, you will provide scientific leadership in the application of epidemiological expertise and methods to answer 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 within the Epidemiology Department, the organization of the Chief Medical Officer, GSK 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 Responsibilities
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, 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 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 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 stakeholders) to meet vaccine 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.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- 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)
- 5+ years of Epidemiology in a pharmaceutical company
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Clinical degree (e.g., in medicine, pharmacy, nursing) and a master-degree in Epidemiology with at least 5-year experience leading pharmaco-epidemiologic research in a vaccine development environment.
- Expertise in infectious disease epidemiology including invasive meningitis disease (IMD) caused by Neisseria meningitidis /and vaccines.
- Good knowledge on nasopharyngeal bacterial (including Neisseria meningococcal) carriage and antimicrobial susceptibility/resistance (AMR) towards bacterial infections including Neisseria meningococcal infections.
- 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 and team 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.
- Developing people and building a talent pipeline.
- 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.
- Budgeting and forecasting, commercial and financial acumen.
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