Associate Director, Clinical Operations

Your experience includes… 

• Bachelor’s degree in a relevant scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and accountable for planning and executing global clinical trials.
• Experience in managing global clinical operations for first-in-human to Phase 3 Programs from start-up to close out, including managing clinical CRO and other vendors, budgets and timelines
• In depth knowledge of ICH/GCP guidelines and working knowledge of regulatory guidelines/directives.
• Proficiency in trial management systems, IVRS/IWRS, eTMF, EDC, SmartSheets and Microsoft applications including Project, PowerPoint, Word and Excel
• FDA and other regulatory inspection experience is a plus
• Current rare disease experience and/or gene therapy experience is highly preferred
• Effective project management skills, cross-functional team leadership and organizational skills
• Ability to thrive in a fast-paced environment with a demonstrated ability to prioritize and manage multiple competing tasks, and flexibility to adapt to changing program needs

You are interested in… 

• Actively