Sarepta Therapeutics · 17 hours ago
Associate Director, Clinical Operations Lead
Cambridge, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$161K/yr - $201K/yr
7+ years expSarepta Therapeutics is a leader in genetic medicine, particularly in Duchenne muscular dystrophy, and is seeking an Associate Director, Clinical Operations Lead. This role is responsible for overseeing clinical operations for assigned studies, providing leadership and guidance, and ensuring compliance with regulatory standards throughout the clinical trial process.
BiotechnologyGeneticsHealth CareTherapeutics
No H1B
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
Qualification
Required
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
Position may require some travel
Bachelor's degree in health sciences or related field
Minimum of 7+ years' experience in clinical research with at least 5 years' experience in study management with strong experience with study phases I-IV, global trials, and with complex trial designs
Line management experience required
Preferred
Program-level experience preferred
Rare disease study management is recommended
Benefits
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
Company
Sarepta Therapeutics
Sarepta Therapeutics focuses on the discovery and development of precision genetic medicine to treat rare diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.88BKey Investors
Michael Andrew ChambersPharmakon AdvisorsMidCap Financial
2025-12-11Post Ipo Debt· $291.4M
2025-08-21Post Ipo Equity
2025-08-21Post Ipo Debt· $602M
Leadership Team
Ian Estepan
Executive Vice President, Chief Financial Officer
K
Kathy Behrens Wilsey
Director
Recent News
2026-01-24
Genetic Engineering News
2026-01-23
Company data provided by crunchbase