Associate Director, Clinical Operations Program Lead, Study Start-up & Feasibility

Sarepta Therapeutics seeks an Associate Director to lead clinical operations for study feasibility and start-up activities. This role directs strategy development, oversees site selection and timelines, and manages cross-functional collaboration with internal teams and external vendors to accelerate clinical trial execution.

Responsibilities

• Develop and implement feasibility and start-up strategies for clinical studies across countries and sites
• Create integrated timelines for feasibility and site start-up; report progress and manage timing risks
• Lead meetings with study teams, MSLs, and CROs to review feasibility data and drive accountability
• Oversee country, site, and investigator selection processes for Sarepta-led studies
• Mentor junior team members and develop reporting tools for key performance and quality indicators

Requirements

• Bachelor's degree in related field; 10+ years clinical operations or project management experience in pharma/biotech
• Expertise in clinical study budget planning, feasibility questionnaires, and protocol/ICF development
• Direct line management and dotted-line reporting experience
• Experience with clinical trial start-up and rare disease populations preferred
• Knowledge of ICH, GCP regulations, and CTMS systems
• Strong organizational, analytical, and presentation skills with ability to manage competing priorities