Epidemiology Director (Waltham) Job at GlaxoSmithKline, Waltham, MA

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  • GlaxoSmithKline
  • Waltham, MA

Job Description

The Director in Epidemiology will support epidemiological strategy for programs led by the Epidemiology Cluster Head- Bacterial vaccines. The goal isto 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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

  • Strategic planning and expanding of epidemiology plans for vaccine development, based on technical expertise in epidemiology and the disease area.
  • Drive 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.
  • 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 studies: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 or a relevant discipline (i.e. health services research, health outcomes research, public health, statistics, or pharmaceutical sciences)
  • Minimum of 5 years of relevant experience
  • Experience leading pharmaco-epidemiologic research in a vaccine development environment.
Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Experience in infectious disease epidemiology including bacterial infections such as invasive meningitis disease (IMD) caused by Neisseria meningitidis /and vaccines.
  • Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings.
  • 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.
Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making using evidence and applying judgement to balance pace, rigour 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.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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, its 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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All emp]]> <

Job Tags

Full time, Contract work, Local area,

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