Associate Director, Clinical Operations Lead

Role Summary

Lead planning, development, and oversight of clinical operations for assigned studies or programs. Provide leadership and line management within Development Operations and guidance on operational deliverables. May lead complex studies with support from one or more Clinical Operations Leads (COLs) and may oversee projects across a program. This is a hybrid role requiring on-site work at Sarepta facilities in the United States and occasional in-person company events.

Responsibilities

• Serve as the subject matter expert within clinical operations for planning and execution of studies across all phases.
• May lead complex studies with the support of COLs, or provide project oversight to studies on a large program.
• Oversee Clinical Research Organizations (CROs), vendors and consultants involved with clinical trials.
• Serve as the point of contact for protocol execution.
• May lead the Clinical Trial Team (CTT) and/or participate in the program Clinical Sub Team.
• May support the Clinical Operations Program Lead (COPL) to operationalize and execute the Clinical Development Plan (CDP).
• Oversee junior team members and ensure alignment with any supporting COLs assigned to studies.
• Establish study timelines in line with company goals and ensure accurate tracking and reporting of study metrics and progress through dashboards.
• Work cross-functionally to ensure clinical program timelines and goals are met and risks are appropriately escalated to the COPL.
• Ensure trial adherence to ICH/GCP/Federal and local regulations and company-specific SOPs.
• Develop, review and/or consult on reports and clinical trial documents such as informed consent, clinical protocols, Investigator Brochure, regulatory updates, and status updates.
• Responsible for communication and escalation of study-related issues to the COPL.
• Provide enrollment forecasting to internal stakeholders, such as Clinical Supply, at agreed frequencies.
• Conduct routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and SOPs and maintain filing of documents or delegate with oversight.
• Participate in and respond to Quality Assurance and regulatory authority inspection audits.
• Facilitate the development of trial budgets and execution of clinical trial agreements and other relevant documents with CROs and internal stakeholders.
• Manage the clinical trial budget and provide financial reporting and projections to Finance.
• Lead creation of scope of work and budgets and escalate vendor performance issues to COPL and Procurement as necessary.
• Serve as an escalation point for more junior study team members and vendors as appropriate.
• Take a leadership role in operational improvement initiatives (e.g., SOP development, training, etc.).
• May have up to four direct reports, including CTAs, COLs, and Sr. COLs.

Qualifications

• Experience in management of CROs, vendors and consultants.
• Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines for patient registries and studies.
• Experience developing trial plans including site management, risk mitigation strategies, trial budgets and program-level budgets.
• Proficient written and verbal communication skills.
• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigators and site staff) using collaborative negotiation skills.
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
• Minimum of 7+ years’ experience in clinical research with at least 5 years’ experience in study management across phases I–IV, global trials, and with complex trial designs.
• Program-level experience preferred; rare disease study management is recommended.
• Line management experience required.

Education

• Bachelor’s degree in health sciences or related field

Additional Requirements

• Hybrid work arrangement with on-site requirements at Sarepta facilities in the United States and/or attendance at Company-sponsored in-person events.
• Some travel may be required.