Job Details

Are you an experienced Real World Evidence Lead (Associate Director) with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Real World Evidence Lead (Associate Director) to work at their company in San Rafael, CA.

Primary Responsibilities/Accountabilities:

This is a hybrid role within the Medical Evidence Generation function, which consists of subject matter experts in evidence planning, study design, and data interpretation. The role involves:

• Implementing real-world evidence study solutions in line with a product's Integrated Evidence Plan under the guidance of a Real World Evidence Product Lead.
• Developing protocols and reporting on disease understanding studies (retrospective and prospective) relevant to the target patient population, including risk factors, natural history, burden of illness, treatment patterns, co-morbidities, co-medications, outcomes measures, and unmet need.
• Supporting post-marketing activities, including the design and/or reporting of post-marketing safety and effectiveness studies/registries, and evaluating risk mitigation strategies.
• Collaborating with external partners in academia or contract research organizations to implement research plans and oversee external groups through the research process.
• Designing secondary data analysis plans of clinical and real-world data to support program strategy.
• Performing targeted literature reviews on the epidemiology of disease, including incidence/prevalence and treatment patterns.
• Working with the commercial team on product forecasts and writing regulatory documents, including Orphan Drug Designation applications.
• Analyzing raw data sets to conduct feasibility analyses and delivering tables/listings/graphs from in-house or licensed real-world datasets promptly.

Qualifications:

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 2 years of experience leading epidemiologic research in the pharmaceutical setting.
• Doctoral degree (PhD, ScD, or DrPH) or Master's degree in a relevant discipline (i.e., Health services research, health outcomes research, public health, statistics, or pharmaceutical sciences) with at least 5 years of experience leading epidemiologic research in the pharmaceutical setting.
• Demonstrated experience conducting pharmaco-epidemiologic research within or in support of the pharmaceutical industry.
• Understanding of statistical and data analysis, research methods, and design.
• Experience with real world data analysis (e.g., EHR, claims, and registry) supporting RWE/pharmacoepidemiology studies, including statistical programming skills (SAS, Python, or R).
• Knowledge of healthcare data standards (e.g., HL7, FHIR), medical terminologies used in healthcare data (e.g., ICD10), EMRs, and regulations (HIPAA, GDPR) is preferred.
• Ability to work in a business-driven environment, balance priorities, and handle multiple tasks through careful planning, stakeholder management, project administration, and organizational skills.
• Self-motivated with the ability to develop credibility with colleagues and interact effectively.
• Ability to individually contribute to activities and projects based on guidance from the Real World Evidence Product Lead.
• Experience in collaborating with internal and external research partners.
• Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence.
• Experience in the Epidemiology of rare diseases or Genetic Epidemiology is a benefit.