9368 Epidemiologist Associate Director
The Epidemiology & Real World Evidence function, contributes to the successful development and commercialization of new therapies in rare disease, providing leadership and expertise to develop and execute Real World Evidence strategies across the spectrum of drug development.
The Associate Director/Director will support one or more compounds, coordinating a multi-disciplinary Data and Evidence Integration (DEI) Team charged with planning and implementation of scientifically robust observational research projects to support early drug development, clinical development programs, regulatory submissions and responses, market access dossiers, and post marketing safety and effectiveness related commitments.
Coordinate Real World Evidence needs and provide technical expertise in Epidemiology methods to develop and maintain a Real World Evidence strategy to support products from clinical development through licensing, market access, and lifecycle management.
Specific activities include:
Understand Real World Evidence needs at the functional level and determine a plan of action to utilize existing Epidemiology evidence or conduct de novo retrospective and prospective research protocols to best address targeted research queries.
Improve disease understanding relevant to the target patient population: incidence, prevalence, risk factors, natural history, burden of illness, treatment patterns, co-morbidities, co-medications, outcomes measures, phenotypes, biomarkers and unmet need, and their variations across demographics and geographies.
Support post marketing activities including design of post marketing safety and effectiveness studies/registries, Epidemiology studies for safety signal detection, evaluation of risk mitigation strategies.
Evaluation and monitoring of literature in therapy area as well as advancements in Epidemiology methods and policy/acceptance of Real World Evidence by regulators/payors.
Develop and negotiate research plans with external collaborators in academia or contract research organizations and work effectively to oversee external groups through the research process.
Effectively communicate observational methodology principles and study findings to an internal and external audience base.
Contribute to the development of SOPs, guidelines, and templates to support conduct of Epidemiology & Real World Evidence studies.
Demonstrated experience conducting pharmaco-epidemiologic research within or in support of the pharmaceutical industry.
Self-motivated with the ability to develop credibility with colleagues and interact effectively and lead multi-disciplinary matrix teams.
Experience in collaborating with research partners.
Ability to work well in a business-driven environment, balance priorities and handle multiple tasks through careful planning, stakeholder management, project administration, and organizational skills. Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings.
Record of high quality, peer reviewed Epidemiology or outcomes research publications preferred. Experience in the Epidemiology of rare diseases or Genetic Epidemiology a benefit.
A combination of academic training and practical experience in Epidemiology is required.
This may consist of:
Doctoral degree (PhD, ScD, or DrPH) or Master’s of Public Health in Epidemiology and at least 5 years of experience leading epidemiologic research in the pharmaceutical setting Doctoral degree (PhD, ScD or DrPH) or Master’s degree in a relevant discipline (ie. Health services research, health outcomes research, public health, statistics, or pharmaceutical sciences) with at least 8 years of experience leading epidemiologic research in the pharmaceutical setting.