Director of Epidemiology Strategy

4 weeks ago

Stevenage, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full time
Job Summary

We are seeking a highly skilled Director of Epidemiology Strategy to join our team at 1925 GlaxoSmithKline LLC. As a key member of our Epidemiology Department, you will be responsible for driving epidemiology strategy and studies across the spectrum of drug development.

About the Role

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 medicine development for an asset or disease area. You will develop and maintain an epidemiology strategy aligned to the drug development strategy, improve disease understanding relevant to drug development, and support and be accountable to advise scientifically on Real World Evidence strategies.

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
• Strengthen the position of the Epidemiology group as a recognized leader in the application of epidemiology to drug development

Requirements

• A combination of academic training and practical experience in epidemiology is required. This may consist of: 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). 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.

Preferred Qualifications

• Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings
• Expertise in epidemiology of respiratory conditions
• 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
• Ability to demonstrate strategic thinking and problem resolution to fill evidence gaps
• Ability to work well within a business-driven environment, balance priorities and handle multiple tasks through careful planning, stakeholder management, project administration, and organizational skills
• Record of high-quality, peer-reviewed epidemiology and/or outcomes research publications and/or demonstrated leadership in external scientific societies/industry-wide collaboration
• Experience in leading epidemiology research in US and EU

About GSK

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).

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