Director Epidemiology Respiratory

GSK•Waltham, MA

4d•Hybrid

About The Position

GSK's Epidemiology Department is seeking a Director to drive Epidemiology strategy and studies across the spectrum of drug development. This role provides scientific leadership in applying epidemiological expertise and methods to address key challenges in medicine development for an asset or disease area, aiming to deliver new medicines more efficiently and effectively to patients. The position is within the Respiratory therapeutic area.

Requirements

A combination of academic training and practical experience in epidemiology is required.
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).
Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters 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.
Demonstrated ability to communicate scientific evidence to peers and at scientific meetings.

Nice To Haves

Expertise in epidemiology of respiratory conditions.
Self-motivated with the ability to work independently to develop credibility with colleagues within and outside Epidemiology.
Ability to 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.

Responsibilities

Develop and maintain an epidemiology strategy aligned to the drug development strategy as a technical expert in epidemiology and the therapeutic area.
Improve disease understanding relevant to drug development, including incidence, prevalence, risk factors, natural history, treatment patterns, co-morbidities, co-medications, outcome measures, phenotypes, biomarkers, and unmet needs, considering variations across demographics and geographies.
Support and advise scientifically on Real World Evidence strategies.
Contribute to medication safety evaluation by providing background event rates, synthesizing existing evidence (including meta-analyses), and identifying high-risk populations.
Propose and lead post-marketing activities such as risk evaluation mitigation strategies, epidemiology studies for signal detection and inference, and post-authorization studies of treatment benefit and risk.
Critically appraise existing epidemiology evidence and create new evidence through research plans, protocols, and analysis of GSK's healthcare databases.
Develop strong partnerships with internal stakeholders (clinical, safety, regulatory, health outcomes, asset leadership) in a multi-disciplinary framework to meet product needs.
Plan resource allocation to accomplish multiple research projects and meet project and study timelines.
Identify innovative, timely, and cost-effective methods for conducting epidemiologic studies.
Negotiate internal funding for projects.
Develop and negotiate research plans with external collaborators (academia or contract research organizations) and work effectively with vendors for outsourced studies.
Communicate study findings effectively to relevant internal and external audiences.
Provide input into regulatory submission documents and represent the function to regulatory agencies as required.
Present the company's position on epidemiology issues and findings to regulatory agencies and other external authorities.
Extend a track record of external publications in peer-reviewed journals to support asset teams.
Strengthen the position of the Epidemiology group as a recognized leader in the application of epidemiology to drug development.