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

The Importance of the Role

We are seeking an associate director-level candidate with clinical operations experience, with specific expertise in feasibility and study start-up, who is interested in applying their experience to develop, build out, and implement innovative feasibility and study start-up activities within Sarepta that positively impacts our clinical programs. The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and lead a team to drive the strategy and implementation of country and site feasibility for our studies and support the internalization of country and site feasibility. Additionally, the candidate will work with early research and other stakeholders to build out the oversight model for Feasibility & Study Start-up. The candidate will drive the study start-up activities and be responsible for oversight of timelines and goals with respect to our clinical studies.

Primary Responsibilities Include

• Develop and implement the feasibility and start-up strategies to support the success of 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.
• Establish study specific meeting series to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO.
• Report metrics to larger teams including senior management.
• Lead calls with Sarepta and the CRO to manage feasibility and study start-up activities and ensure the study timelines are achieved.
• Oversee study feasibility activities including country, site, and investigator selection for participation in Sarepta-lead studies.
• Foster a culture of innovation by developing new ideas and programs to advance feasibility and support departmental growth.
• Provide guidance and mentoring to junior members of the Study Start-up and Feasibility Team.
• Create reporting tools to measure ongoing activities and other key performance, quality, and effectiveness indicators.
• Partner with Clinical Operations and CRO teams, and other key stakeholders to implement innovative feasibility efforts including collection of data within CTMS.
• Support and or lead the development of Charters or SOPs as it relates 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
• Ability to multi-task, work independently and as part of a multidisciplinary team, exercise sound judgement and escalate issues when necessary