Jobs at Sarepta Therapeutics

Manage infrastructure, planning, tracking, and execution of outside-US (OUS) International Business initiatives. Coordinate cross-functional project plans and launches, run meetings and action-item follow-up, maintain tracking tools and reporting, manage vendors and contracts, and partner with Global Access and Patient Services to ensure compliant, scalable operations.

As the Director of Biostatistics, you will lead statistical efforts in clinical trials, oversee statistical deliverables, and collaborate with cross-functional teams to enhance precision genetic medicine.

Support planning and execution of international supply chain for commercial programs. Coordinate global distribution, inventory, import/export documentation, and trade compliance. Partner cross-functionally to resolve operational issues, perform scenario planning and risk mitigation, and drive process and system improvements while delivering accurate data and reporting.

Lead the Biometrics team to provide statistical strategies for clinical development and regulatory submissions while overseeing collaborations and ensuring compliance in statistical methodologies.

Provide GCP-focused QA oversight for clinical development and real-world evidence programs. Lead integration of acquired programs, vendor and site audits, CAPA development, inspection readiness, review of clinical documentation, and continuous improvement of the Quality Management System. Partner cross-functionally to resolve compliance issues and manage external audit consultants.

Lead global labeling and clinical trial disclosure activities for development and marketed products. Develop and harmonize CCDS, US prescribing information, local labeling, and manage trial registration/results posting. Partner cross-functionally and with vendors, support regulatory strategy and Health Authority interactions, and ensure documentation and compliance.

Lead SOX 404 compliance and support external financial reporting and technical accounting. Coordinate control documentation, testing, remediation, and audit interactions. Prepare and review SEC filings (10-Q, 10-K), XBRL, disclosures, and supporting schedules. Analyze complex and non-recurring transactions, develop accounting policies, and collaborate with FP&A, Legal, Investor Relations, and auditors to ensure accuracy and timely reporting.

Lead and execute GPV and GLP/GCLP vendor audits, develop audit plans and reports, review vendor responses, support GxP inspections, maintain audit schedules and records, and revise GxP quality documentation to ensure regulatory compliance.

Lead end-to-end process development for oligonucleotide and siRNA therapies from preclinical through commercialization. Define phase-appropriate strategies, scale-up, tech transfer, CDMO oversight, and QbD-aligned control strategies. Provide technical and regulatory support for CMC documentation, investigations, and validation readiness while collaborating across functions to enable clinical and commercial manufacturing.

Lead and manage all operational aspects of assigned complex clinical trials, including CRO/vendor oversight, study timelines, budgets, TMF compliance, cross-functional coordination, risk escalation, and mentoring junior staff. Ensure regulatory/GCP adherence, participate in audits, and drive trial planning and vendor performance.

The Associate Director, HR Business Partner leads strategic people initiatives, partners with senior leaders, and drives organizational effectiveness at Sarepta. Key responsibilities include talent management, organizational design, change management, and employee engagement.

Lead pharmacovigilance (GVP) quality oversight and audit program; design and execute audit strategy; manage audit reports, CAPA, and remediation; support inspection readiness and regulatory interactions; review SOPs and QMS elements; collaborate cross-functionally to identify risks and ensure sustainable compliance.

Lead development and maintenance of lifecycle forecasting models and scenario analyses for Sarepta's in-line and pipeline therapies. Partner cross-functionally to produce demand forecasts, sensitivity analyses, and decision-ready insights to support commercial planning (S&OP, LRP, LEs), HCP targeting, and leadership/board discussions. Monitor market dynamics, drive ad hoc analyses, and improve forecasting capabilities and variance reporting.

Co-manage Sarepta's global GxP training program: maintain compliant training systems (Veeva Training Vault), design and deliver GxP eLearning, manage SOPs and qualification records, support inspections, perform LMS validation/upgrades, generate reports, and provide cross‑functional training operations and end‑user support.