Senior Clinical Scientist, Rare Disease
4 days ago
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.
-
Senior Clinical Scientist, Rare Disease
1 week ago
San Mateo, United States CSG Talent Full timeSenior 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...
-
Senior Clinical Scientist, Rare Disease
1 week ago
San Mateo County, CA, United States CSG Talent Full timeSenior 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,...
-
Senior Clinical Scientist, Rare Disease
1 week ago
San Mateo County, United States CSG Talent Full timeSenior 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...
-
Senior Clinical Scientist, Rare Disease
1 week ago
San Mateo County, United States CSG Talent Full timeSenior 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...
-
San Mateo, United States Dompé Full timeA biotechnology firm is seeking a Senior Director, Commercialization Lead, to drive the launch of a rare disease therapy. The role includes shaping the commercial strategy, leading pre-launch planning, and collaborating with various functions to ensure success. The ideal candidate will have extensive experience in product commercialization, particularly in...
-
Rare Disease Account Manager, Metabolic
3 weeks ago
San Francisco, United States Recordati Rare Diseases North America Full timeRare Disease Account Manager, Metabolic (California) Join to apply for the Rare Disease Account Manager, Metabolic (California) role at Recordati Rare Diseases North America Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate...
-
Project Manager
1 week ago
San Diego, CA, United States EPM Scientific Full timeClinical Project Manager - Rare Disease San Diego, CA - On- Site $115,000 - $140,000 A clinical-stage biotech company in San Diego is seeking a Clinical Development Operations Lead to manage global clinical trials and support regulatory strategy across a diverse pipeline. This role is ideal for someone with a strong foundation in clinical research,...
-
Vice President, Clinical Development
2 weeks ago
San Diego, CA, United States Travere Therapeutics Full timeDepartment: 106750 Clinical Development Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients....
-
Staff Scientist/ Senior Scientist Full-time
2 weeks ago
San Francisco, CA, United States GondolaBio Full timeGondolaBio is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for genetic diseases. Originally launched as BridgeBioX, a subsidiary of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. The company aims to...
-
Project Manager
1 week ago
San Diego, United States EPM Scientific Full timeClinical Project Manager - Rare Disease San Diego, CA - On- Site $115,000 - $140,000 A clinical-stage biotech company in San Diego is seeking a Clinical Development Operations Lead to manage global clinical trials and support regulatory strategy across a diverse pipeline. This role is ideal for someone with a strong foundation in clinical research,...