Atsena Therapeutics
11 - 50 employees
🧬 Biotechnology
🏥 Healthcare
💰 $150M Series C - Atsena Therapeutics on 2025-04
Biotechnology • Healthcare
Atsena Therapeutics is a clinical-stage gene therapy company developing first- and best-in-class treatments for inherited retinal diseases. Its lead program, ATSN-201, is in a pivotal Phase 3 trial for X-linked retinoschisis (XLRS); other programs include ATSN-101 for LCA1 (pivotal trial planned), and earlier-stage assets targeting Usher Syndrome 1B and Stargardt disease. Atsena uses proprietary AAV-based delivery platforms — notably the laterally spreading capsid AAV. SPR and a dual vector technology — engineered to address retinal delivery challenges and to enable larger gene payloads. The company focuses on advancing ocular gene therapies through clinical development.
Associate Director, CMC Regulatory Affairs
🕒 6 days ago
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Atsena Therapeutics
11 - 50 employees
🧬 Biotechnology
🏥 Healthcare
💰 $150M Series C - Atsena Therapeutics on 2025-04
Biotechnology • Healthcare
Atsena Therapeutics is a clinical-stage gene therapy company developing first- and best-in-class treatments for inherited retinal diseases. Its lead program, ATSN-201, is in a pivotal Phase 3 trial for X-linked retinoschisis (XLRS); other programs include ATSN-101 for LCA1 (pivotal trial planned), and earlier-stage assets targeting Usher Syndrome 1B and Stargardt disease. Atsena uses proprietary AAV-based delivery platforms — notably the laterally spreading capsid AAV. SPR and a dual vector technology — engineered to address retinal delivery challenges and to enable larger gene payloads. The company focuses on advancing ocular gene therapies through clinical development.
📋 Description
• Lead global CMC regulatory strategy and execution for gene therapy programs. • Develop and implement global CMC regulatory strategies for gene therapy programs. • Prepare and review CMC sections of global regulatory submissions. • Support agency meetings and serve as subject matter expert.
🎯 Requirements
• PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or related field. • Direct experience with AAV, lentiviral, or other gene therapy platforms. • 7–10 years of experience in regulatory affairs and CMC for Associate Director position. • 10–15+ years of experience in regulatory affairs for Director position. • Familiarity with global regulatory frameworks for advanced therapy medicinal products (ATMPs). • Excellent regulatory writing and communication skills.
🏖️ Benefits
• Health insurance • Flexible work arrangements • Professional development
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