Real World Evidence Lead
BioMarin Pharmaceutical Inc.
June 25, 2026
Remote friendly (San Rafael, CA)
United States
Clinical Research and Development
Real World Evidence Lead (Director)
Key Responsibilities:
- Set and lead strategy for real-world/observational evidence generation across assigned program(s)/therapy area(s), aligning with the Integrated Evidence Plan and key value, access, and regulatory decision points.
- Lead implementation of real-world evidence studies per the Integrated Evidence Plan, including:
- Develop and report protocols for disease understanding studies (retrospective/prospective) with fit-for-purpose design to characterize target populations, inform program decisions, and address unmet need.
- Lead post-marketing evidence strategy and delivery (safety/effectiveness studies and registries), overseeing risk mitigation evaluation and alignment to risk management plans and real-world regulatory commitments.
- Establish and implement research plans with external collaborators (CROs, academia, data partners) to ensure high-quality outputs.
- Define and oversee secondary data analysis strategy using BioMarin clinical and real-world data.
- Interpret and synthesize real-world evidence for internal governance and senior stakeholders; drive external dissemination (manuscripts, abstracts, posters, presentations).
- Serve as an evidence partner to Commercial, Market Access, and Regulatory to reflect real-world evidence in forecasts, value narratives, and regulatory deliverables.
Desired Experience (Required):
- PhD/ScD/DrPH or MPH in Epidemiology/Pharmacoepidemiology with 8+ years leading epidemiologic research in the pharmaceutical industry; or PhD/ScD/DrPH or Master’s in a relevant discipline with 10+ years in the pharmaceutical setting.
Skills/Preferred:
- Leadership in pharmacoepidemiologic/real-world evidence research; translation of evidence strategy into study concepts/protocol portfolios.
- Experience authoring/providing scientific accountability for protocols, SAPs, and study reports.
- Expertise in observational study design, bias/confounding mitigation, data quality assessment, and fit-for-purpose inference.
- Knowledge of healthcare data ecosystems/standards (HL7, FHIR), clinical terminologies (ICD-10), EMR/claims data, and privacy governance (GDPR, HIPAA).
- Ability to lead regulator/ethics body engagement (e.g., HA queries, IRB/EC).
- Ability to manage priorities in a business-driven matrix environment.
- Experience in rare disease and/or genetic epidemiology (preferred).
Key Responsibilities:
- Set and lead strategy for real-world/observational evidence generation across assigned program(s)/therapy area(s), aligning with the Integrated Evidence Plan and key value, access, and regulatory decision points.
- Lead implementation of real-world evidence studies per the Integrated Evidence Plan, including:
- Develop and report protocols for disease understanding studies (retrospective/prospective) with fit-for-purpose design to characterize target populations, inform program decisions, and address unmet need.
- Lead post-marketing evidence strategy and delivery (safety/effectiveness studies and registries), overseeing risk mitigation evaluation and alignment to risk management plans and real-world regulatory commitments.
- Establish and implement research plans with external collaborators (CROs, academia, data partners) to ensure high-quality outputs.
- Define and oversee secondary data analysis strategy using BioMarin clinical and real-world data.
- Interpret and synthesize real-world evidence for internal governance and senior stakeholders; drive external dissemination (manuscripts, abstracts, posters, presentations).
- Serve as an evidence partner to Commercial, Market Access, and Regulatory to reflect real-world evidence in forecasts, value narratives, and regulatory deliverables.
Desired Experience (Required):
- PhD/ScD/DrPH or MPH in Epidemiology/Pharmacoepidemiology with 8+ years leading epidemiologic research in the pharmaceutical industry; or PhD/ScD/DrPH or Master’s in a relevant discipline with 10+ years in the pharmaceutical setting.
Skills/Preferred:
- Leadership in pharmacoepidemiologic/real-world evidence research; translation of evidence strategy into study concepts/protocol portfolios.
- Experience authoring/providing scientific accountability for protocols, SAPs, and study reports.
- Expertise in observational study design, bias/confounding mitigation, data quality assessment, and fit-for-purpose inference.
- Knowledge of healthcare data ecosystems/standards (HL7, FHIR), clinical terminologies (ICD-10), EMR/claims data, and privacy governance (GDPR, HIPAA).
- Ability to lead regulator/ethics body engagement (e.g., HA queries, IRB/EC).
- Ability to manage priorities in a business-driven matrix environment.
- Experience in rare disease and/or genetic epidemiology (preferred).