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 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
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 writing and cross-functional collaboration skills
Experience in rare disease, pediatric, neurodegenerative, or biologics programs preferred
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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