Associate Director, Clinical Operations Lead

Role Summary

The Associate Director, Clinical Operations Lead is responsible for the planning, implementation, conduct, and oversight of clinical operations for assigned studies or programs. This role provides leadership and line management within Development Operations and guidance on operational deliverables. The AD COL may lead complex studies with support from one or more Clinical Operations Leads (COLs) and/or may provide 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 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 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 SOPs and ensures all appropriate documents are filed (or delegated with oversight).
• Participates in Quality Assurance and/or regulatory authority inspection audits.
• In conjunction with CROs and 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 members internally and with vendors.
• Assumes a 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 investigators 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.

Skills

• Written and verbal communication skills.
• Collaborative negotiation skills and ability to work with study teams and external partners.
• Proficient computer skills including Excel, Word, PowerPoint, Outlook and MS Project.

Additional Requirements

• Position may require some travel.
• Hybrid work arrangement: on-site at a Sarepta facility in the United States and/or attendance at Company-sponsored in-person events from time to time.