Associate Director, Clinical Operations

Clinical Trial Leadership & Execution:

• Support operational planning, start-up, execution, and close-out activities for Phase 3 clinical studies in HCM.
• Oversee CROs, vendors, clinical sites, and external partners to ensure delivery of high-quality data, adherence to timelines, and compliance with GCP and regulatory requirements.
• Support development and review of study protocols, operational plans, ICFs, monitoring plans, study manuals, and training materials.

Vendor & Site Management:

• Lead selection, onboarding, and oversight of CROs, central labs, imaging vendors, and specialty service providers.
• Ensure vendors meet contractual obligations, quality expectations, and KPIs while maintaining transparent communication and issue resolution.
• Support site engagement strategies, including feasibility, site communications, and escalation management.

Compliance, Quality, & Process Excellence:

• Ensure clinical trial conduct complies with ICH/GCP, SOPs, and global regulatory expectations.
• Support SOP development, process improvements, and consistent implementation of best practices across the clinical operations function.
• Contribute to inspection-readiness activities and support responses to regulatory agency queries as needed.