Senior Clinical Scientist, Rare Disease (PhD) Job at CSG Talent, San Mateo County, CA

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  • CSG Talent
  • San Mateo County, CA

Job Description

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 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 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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