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Real World Evidence Lead (Biotech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Real World Evidence Lead (Biotech): Leading real-world and observational evidence strategies for rare-disease programs, with an accent on epidemiologic research, post-marketing evidence, data analysis, and regulatory decision support. Focus on designing studies and protocols, interpreting healthcare data, overseeing CRO and academic collaborators, and translating complex evidence into recommendations for senior stakeholders and scientific dissemination.
Location: San Rafael and Novato, California, United States
Company
BioMarin is a rare disease biotechnology company developing therapies for genetically defined conditions and supporting patients through research, clinical development, and manufacturing.
What you will do
- Set and lead real-world and observational evidence strategies for assigned programs or therapy areas.
- Lead disease understanding studies, including retrospective and prospective research on target populations, treatment patterns, outcomes, and unmet needs.
- Direct post-marketing evidence strategies, including safety and effectiveness studies, registries, and risk mitigation evaluations.
- Establish research plans with CROs, academic institutions, data partners, and other external collaborators.
- Define secondary data analysis strategies and synthesize evidence into recommendations for governance and senior stakeholders.
- Partner with Commercial, Market Access, and Regulatory teams on forecasts, value narratives, regulatory submissions, publications, and scientific presentations.
Requirements
- Doctoral degree in epidemiology or a relevant discipline with at least 8 years of pharmaceutical-industry epidemiology experience, or a relevant master's degree with at least 10 years of experience.
- Leadership experience in pharmacoepidemiology and real-world evidence research within or supporting the pharmaceutical or biotechnology industry.
- Extensive experience with evidence strategy, study concepts, protocols, statistical analysis plans, and study reports.
- Deep expertise in observational study design, advanced analytics, bias and confounding mitigation, data quality assessment, and fit-for-purpose inference.
- Knowledge of healthcare data ecosystems and standards, including HL7, FHIR, ICD-10, EMR, claims data, GDPR, and HIPAA.
- Experience engaging with regulators and ethics bodies, managing matrix stakeholders, and communicating complex evidence clearly.
Nice to have
- Experience in rare disease or genetic epidemiology, including small populations, registries, and novel endpoints.
Culture & Benefits
- Work within a global research and development organization focused on rare-disease therapeutics.
- Collaborate with scientific, clinical, commercial, market access, regulatory, academic, and data-partner teams.
- Contribute to evidence that supports patient care, clinical adoption, long-term safety, and treatment effectiveness.
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