Epidemiology Director

3 weeks ago

Stevenage, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full time
Key Responsibilities
  • Develop and maintain an epidemiology strategy aligned to the drug development strategy.
  • Improve disease understanding relevant to drug development: incidence, prevalence, risk factors, natural history course, treatment patterns, co-morbidities, co-medications, outcome measures, phenotypes, 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 signal detection and inference, post-authorization studies of treatment benefit and risk.
  • 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, 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 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.
Basic Qualifications
  • A combination of academic training and practical experience in epidemiology is required. This may consist of: Doctoral degree (Ph.D., Sc.D or Dr.P.H) in epidemiology or a relevant discipline (i.e. health services research, health outcomes research, public health, statistics or pharmaceutical sciences). Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in Epidemiology with 5+ years experience leading pharmaco-epidemiologic research in a drug development environment. Experience leading pharmaco-epidemiologic research programs in a drug development environment.

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