Associate Director, Clinical Operations Lead

Role Summary

As the Associate Director, Clinical Operations Lead, you will plan, implement, conduct, and oversee clinical operations for assigned studies or programs. You will provide leadership and line management within Development Operations and guide operational deliverables. You may lead complex studies with the support of one or more COLs, or oversee project oversight across studies within a program.

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 may 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 stakeholder, 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 ~4 direct reports consisting of CTAs, COLs, 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
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project
• 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 role with on-site work at Sarepta facilities in the United States and/or attendance at Company-sponsored in-person events from time to time
• Position may require some travel
• Candidates must be authorized to work in the U.S.