Associate Director/Director Epidemiology & Real World Evidence

Location:  San Rafael, California Category: Medical Affairs

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. 
 

Description          

The Epidemiology & Real World Evidence function at BioMarin contributes to the successful development and commercialisation 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 BioMarin compounds, coordinating a multi-disciplinary Data and Evidence Integration 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.

 

Duties

  • 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 utilizing 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

Skills

  • 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

 

 

Education

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

 
 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.