Director, Epidemiology – Respiratory

Responsibilities

• As a technical expert in epidemiology and the therapeutic area, 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‑morbidity, 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.

• Doctoral degree (PhD, ScD or DrPH) in epidemiology (preferred) or a relevant discipline.
• Clinical degree (e.g., in medicine, pharmacy, nursing) and a master's degree in Epidemiology with at least five years experience leading pharmaco‑epidemiologic research in a drug development environment.
• Demonstrable experience leading pharmaco‑epidemiologic or translational epidemiology research programmes in a drug development environment.
• Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings.