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

Primary Responsibilities

• Develop and implement feasibility and start-up strategies to support the success of Sarepta’s clinical studies.
• Oversee study feasibility activities, including country, site, and investigator selection for participation in Sarepta clinical studies.
• Gather cross-functional, country-level input to inform robust feasibility strategies.
• Develop and manage integrated feasibility and site start-up timelines, and report on progress, including plans to address potential timing risks or gaps.
• Create reporting tools to measure ongoing activities, as well as key performance, quality, and effectiveness indicators.
• Partner with Clinical Operations, CRO teams, and other key stakeholders to implement innovative feasibility initiatives, including data collection within CTMS.
• Support and/or lead the development of charters and SOPs related to Study Start-up and Feasibility.
• May have direct reports.

Desired Education And Skills

• BA/BS degree in a related field; 10+ years related experience in the pharmaceutical or biotech industry within a clinical operations or project management role or similar.
• Experience in clinical study budget planning, and program implementation.
• Experience with both direct line management and dotted line reporting.
• Experience in developing feasibility questionnaires.
• Experience with protocol and ICF development and review.
• Experience in clinical study start-up.
• Experience with rare disease / difficult to recruit populations a plus.
• Experience identifying and managing multiple CROs, vendors, budgets, KPIs.
• Comprehensive regulatory knowledge, including ICH and GCPs.
• Exceptional organizational skills and ability to deal with competing priorities.
• Strong analytical reasoning and problem-solving ability.
• Excellent PowerPoint slide development and presentation skills.
• Able to multi-task, work independently and as part of a multidisciplinary team, exercise sound judgement and escalate issues when necessary.