Real World Evidence Lead

Role: Director of Real World Evidence (RWE) strategy and execution for rare disease therapies, focusing on observational and post-marketing studies to inform clinical, regulatory, and commercial decisions. Responsibilities: develop and lead RWE strategies aligned with program goals, oversee study protocol development (retrospective/prospective), manage external collaborations with CROs and data partners, and lead data analysis and interpretation. Drive publication efforts and ensure integration of RWE findings into regulatory and market access plans. Requirements: doctoral (PhD, ScD, DrPH) in Epidemiology, Public Health, or related field with 8+ years (or master's with 10+ years) of epidemiologic research experience in pharma/biotech. Skills: expertise in observational study design, advanced analytics, healthcare data standards (HL7, FHIR, ICD-10), regulatory engagement, and stakeholder management. Preferred: experience in rare or genetic diseases, working with small populations, registries, and novel endpoints. High-Value: rare disease therapeutic focus, post-market evidence, epidemiology, health outcomes research, and cross-functional collaboration with Regulatory, Commercial, and Medical teams.