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Real World Evidence Lead (Associate Director)
750 Lindaro Street San Rafael, CA 94903 US
Job Description
The Real World Evidence Leads are part of the Medical Evidence Generation function comprised of subject matter experts in evidence planning, study design and data interpretation. The function works to drive excellence in evidence planning and implement novel study design approaches to generate robust evidence to enhance understanding of unmet medical need; support patient and endpoint selection for Clinical studies; and inform clinical practice on appropriate use and long-term safety and effectiveness of company products. This position will report to the Real World Evidence Product Lead.
Duties
- Implement real world evidence study solutions studies in-line with a product’s Integrated Evidence Plan under the guidance of a Real World Evidence Product Lead. Specific activities include:
- Protocol development and reporting of 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
- Support post marketing activities including design and/or reporting of post marketing safety and effectiveness studies/registries, evaluation of risk mitigation strategies
- Support implementation of research plans with external collaborators in academia or contract research organizations and work effectively to oversee external groups through the research process
- Designs secondary data analysis plans of company clinical and real-world data to support program strategy
- Perform targeted literature review of epidemiology of disease, including incidence/prevalence and treatment patterns; work with commercial team on product forecasts and write regulatory documents including Orphan Drug Designation applications
- Analyze raw data sets to conduct feasibility analyses and deliver tables/listings/graphs from in-house or licensed real world datasets in a timely manner
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 (ie. 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 (combination of education and work) 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 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 a benefit
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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