Senior Clinical Scientist, Rare Disease

1 week ago


San Mateo County, United States CSG Talent Full time

Senior Clinical Scientist, Rare Disease (PhD)We are seeking a PhD-level Clinical Scientist to support the Biologics License Application (BLA) submission for a Breakthrough Therapy-designated biologic targeting a neurodegenerative rare disease.This role will contribute to late-stage clinical development, supporting clinical data interpretation, regulatory documentation, and cross-functional collaboration as the program advances toward potential approval.Key ResponsibilitiesSupport late-stage clinical development and BLA submission activitiesInterpret and synthesize clinical efficacy, safety, and biomarker data in pediatric populationsAuthor and review clinical sections of regulatory documents (Modules 2 and 5)Collaborate cross-functionally with Regulatory, Clinical Operations, Biostatistics, and Medical AffairsSupport FDA interactions and regulatory meetings as neededQualificationsPhD in a life sciences discipline5+ years of clinical development experience in biotech or pharmaExperience supporting late-stage programs and regulatory submissions (BLA/NDA/MAA)Strong scientific writing and cross-functional collaboration skillsExperience in rare disease, pediatric, neurodegenerative, or biologics programs preferredWhy This RoleThis is an opportunity to contribute to a Breakthrough Therapy-designated biologic at a critical regulatory milestone, advancing a program aimed at addressing serious unmet need in pediatric neurodegenerative disease.



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