Associate Director, Clinical Trial Lead

Role: Senior Clinical Trial Operations Manager responsible for designing and overseeing operational strategies for multiple neurological clinical studies across phases, including nephrotic conditions, MS, Alzheimer’s, and SMA. Responsibilities: lead study-level planning, chair Study Management Teams, oversee CRO execution to ensure quality, timeliness, and budget adherence, and develop risk mitigation and issue resolution strategies. Establish efficient team operations and promote process compliance and cross-study synergies.

Qualifications: Bachelor’s in a scientific discipline, 8+ years in clinical operations management with experience overseeing outsourced trials, strong knowledge of GCP, ICH guidelines, and regulatory requirements. Proven project management, risk assessment, and CRO management skills essential.

Preferred: Experience in nephrology studies, advanced degrees (Master’s or Ph.D.), investigator site/monitoring background.

High-Value specifics: Focus on neurological indications, managing global clinical trials in multiple phases, working within GCP/ICH regulatory frameworks, and collaborating with CROs and internal teams. Work setup offers flexible hybrid/remote options; travel requirements not specified.