Director Epidemiology

5 months ago

Mississauga, Canada GSK Full time

**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).

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.

**_ 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 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 priori

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