Clinical Development Associate

Roles & Responsibilities
• Coordinate GLP toxicology studies with CROs, including timelines, tracking, and review of study reports
• Support CMC readiness by compiling specifications, development data, and technical documentation
• Assist in preparation of IND/CTA submissions with focus on nonclinical and CMC sections
• Manage cross-functional coordination with R&D, QA, CROs, and external partners
• Maintain regulatory-ready documentation, trackers, and development logs
• Support IND-enabling activities for late preclinical development programs

Qualification
• MS / M.Pharm / M.Sc in Life Sciences, Pharmacy, or Biotechnology

Experience
• 2-3 years of experience in clinical development, preclinical development, or regulatory support
• Hands-on exposure to GLP toxicology coordination, CMC documentation, or IND submissions

Skills
• Strong understanding of GLP toxicology and CMC development workflows
• Working knowledge of CDSCO and/or US FDA IND processes
• Excellent documentation, organizational, and follow-up skills
• Ability to work effectively in cross-functional and CRO-facing environments
• Good communication and coordination abilities

About the Company
Utopia Therapeutics is an emerging biopharmaceutical company focused on advancing innovative therapies through robust preclinical and clinical development. With active IND-enabling programs and a science-driven culture, the company provides hands-on exposure, close collaboration with senior scientists, and strong career growth opportunities in clinical development and regulatory affairs.