Senior Clinical Scientist, Rare Disease

4 days ago


San Mateo CA, United States CSG Talent Full time

Senior Clinical Scientist, Rare Disease (PhD) Please make an application promptly if you are a good match for this role due to high levels of interest. 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 Responsibilities Support late-stage clinical development and BLA submission activities Interpret and synthesize clinical efficacy, safety, and biomarker data in pediatric populations Author and review clinical sections of regulatory documents (Modules 2 and 5) Collaborate cross-functionally with Regulatory, Clinical Operations, Biostatistics, and Medical Affairs Support FDA interactions and regulatory meetings as needed Qualifications PhD in a life sciences discipline 5+ years of clinical development experience in biotech or pharma Experience supporting late-stage programs and regulatory submissions (BLA/NDA/MAA) Strong scientific xrczosw writing and cross-functional collaboration skills Experience in rare disease, pediatric, neurodegenerative, or biologics programs preferred Why This Role This 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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