Associate Director, Clinical Operations Lead

Role Summary

Role: Associate Director, Clinical Operations Lead. The Associate Director is responsible for the planning, implementation, conduct, and oversight of clinical operations for assigned studies or programs, providing leadership within Development Operations and guidance on operational deliverables. The AD COL may lead complex studies with the support of one or more COLs and/or oversee project delivery across studies within a program. This is a hybrid role based in the United States, with on-site work at Sarepta facilities and occasional in-person events.

Responsibilities

• Serve as the subject matter expert within clinical operations for the planning and execution of studies across all phases
• May lead complex studies with the support of one or more COLs, or may provide project oversight to one or more studies on a large program
• Oversees Clinical Research Organizations (CROs), vendors and consultants involved with the clinical trials
• Serves 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)
• Oversees junior team members and ensures alignment with any supporting COLs assigned to studies
• Establishes study timelines in line with company goals and ensures accurate tracking and reporting of study metrics and progress through completion of study dashboards
• Works cross-functionally to ensure clinical program timelines and goals are met and risks are appropriately escalated to the COPL
• Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
• Develops, reviews and/or consults on reports and clinical trial documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates
• Responsible for communication and escalation of study related issues to the COPL
• Provides enrollment forecasting to internal stakeholders, such as Clinical Supply, at agreed upon frequency
• Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed, or delegates activity with oversight
• Participates and responds to Quality Assurance and/or regulatory authority inspection audits
• In conjunction with CRO and appropriate internal stakeholders, facilitates the development of trial budgets and execution of clinical trial agreements and other relevant documents
• Manages the clinical trial budget and provides financial reporting and projections to Finance
• Leads creation of scope of work and budgets and escalates vendor performance issues to COPL and Procurement as necessary
• May serve as an escalation point for more clinical operations team study team members internally and with vendors
• Assume leadership role in operational improvement initiatives (e.g., SOP development, training, etc.)
• Up to approximately 4 direct reports consisting of 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 investigator and site staff) using collaborative negotiation skills
• Program-level experience preferred. Rare disease study management is recommended.
• Line management experience required
• Minimum of 7+ years’ experience in clinical research with at least 5 years’ experience in study management with strong experience in study phases I–IV, global trials, and with complex trial designs

Skills

• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project

Education

• Bachelor’s degree in health sciences or related field

Additional Requirements

• Travel may be required