Director Epidemiology Vaccines
il y a 1 semaine
Site Name:
Belgium-Wavre, GSK House, USA - Massachusetts - Waltham
Posted Date:
Apr
Locations
Belgium-Wavre
UK-GSK House, London*US-Boston (Waltham), MA
Would you like to be part of GSK's Value Evidence Outcomes (VEO) 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 within programs led by the Epidemiology Cluster Head
- Bacterial vaccines within the context of the GSK Vaccines process; the goal is to ensure the high quality and ontime delivery of epidemiology data that will allow and support worldwide registration in compliance with the epidemiology development plan, applicable good practices, and GSK Vaccines standard operating procedures (SOP).
This position functions within the Epidemiology & Patient Centered Outcomes Department, part of R&D VEO, 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 support strategy aligned to the vaccine development strategy
- Improve disease understanding relevant to vaccine development: incidence, prevalence, risk factors, natural history course, treatment patterns, comorbidities, comedications/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 metaanalyses, identify highrisk populations.
- Propose and lead postmarketing activities: risk evaluation mitigation strategies, epidemiology studies for signal detection and inference, postauthorization 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 multidisciplinary framework (clinical, safety, regulatory, health outcomes, asset leadership) to meet product needs.
- Plan resource allocation to accomplish multiple research projects and attain project and study timelines.
- Identify innovative, timely and costeffective 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:
- 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) with at least 5year experience
- Clinical degree (e.g., in medicine, pharmacy, nursing) and a masterdegree in Epidemiology with at least 5year experience leading pharmacoepidemiologic research in a vaccine development environment.
- Demonstrable experience leading pharmacoepidemiologic research programs in a vaccine development environment.
- Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings.
Preferred Qualifications:
- Expertise in epidemiology of bacterial diseases/vaccines
- Good knowledge on nasopharyngeal bacterial carriage and antimicrobial susceptibility/resistance (AMR)
- Selfmotivated with the ability to work independently to develop credibility with colleagues within and outside Epidemiology, as well as interact effectively in multidisciplinary matrix teams to influence decisions.
- Broad experience in collaborating with research partners
- Problemsolver; ability to see solutions to complex, uni
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