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Real World Evidence Lead (Associate Director)

San Rafael, CA 94903

Posted: 04/15/2025 Employment Type: Contract Job Category: Medical Affairs Job Number: 619042 Is job remote?: Hybrid Country: United States

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
Requirements:
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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About San Rafael, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Rafael, California area! Nestled in Marin County, San Rafael offers a perfect blend of picturesque landscapes, cultural attractions such as the Marin Veterans' Memorial Auditorium and the Marin History Museum, and a thriving culinary scene with diverse eateries like Sol Food and Terrapin Crossroads. This charming city also boasts easy access to outdoor adventures at China Camp State Park and opportunities to appreciate local art at the Falkirk Cultural Center. Join us in San Rafael, where career growth meets undeniable charm – apply now and discover your next career move in this dynamic region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.