GlaxoSmithKline
Director Epidemiology - Bacterial Vaccines
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Site Name:
Upper Providence, Belgium-Wavre, Mississauga, USA - Massachusetts - WalthamPosted Date:
Aug 20 2024Would 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.Why you?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 companyPreferred 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/regionsExperience in leading epidemiology research in US, EU, and Asia-PacificAgile 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.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 people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Upper Providence, Belgium-Wavre, Mississauga, USA - Massachusetts - WalthamPosted Date:
Aug 20 2024Would 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.Why you?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 companyPreferred 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/regionsExperience in leading epidemiology research in US, EU, and Asia-PacificAgile 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.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 people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.