Jobs at Sarepta Therapeutics

Leads quantitative and clinical pharmacology strategies across drug development through registration. Responsibilities include dose selection, population PK/PD modeling and simulation, translational and mechanistic analyses, clinical study support, regulatory strategy, health authority engagement, data review, reporting, publications, and scientific presentations.

Leads global regulatory strategy and health authority interactions for clinical and commercial therapeutic programs. Oversees preparation and quality of INDs, CTAs, NDAs, briefing packages, reports, and correspondence. Coordinates cross-functional regulatory teams, guides clinical and nonclinical teams, manages submission activities, identifies and mitigates risks, oversees junior personnel, and manages budgets and schedules. Represents the company before FDA and global regulatory agencies.

Leads Sarepta’s scientific technology and laboratory systems organization, overseeing laboratory applications, LIMS, ELN, instrument technology, software development, governance, vendors, budgets, risk, and service delivery. Develops multi-year roadmaps, matures operating models, manages approximately 20 employees and contractors, and partners with Research, Quality, Manufacturing, Information Security, and Validation. The role advances scalable laboratory technology, automation, AI, lifecycle management, operational resilience, and compliant systems across a regulated life sciences environment.

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.

Leads statistical strategy and execution for clinical trials from protocol design through analysis, reporting, and regulatory submission. Serves as study and future program statistical lead, guiding adaptive trial design, pivotal analyses, integrated analyses, and regulatory interactions. Partners cross-functionally, oversees CROs and programmers, independently develops analyses in R or SAS, and mentors statisticians and programmers while helping build the Biostatistics function.

Leads corporate quality oversight for clinical development and real-world evidence programs. Provides GCP and GLP compliance guidance, partners with R&D and pharmacovigilance teams, resolves vendor and investigator-site deficiencies, develops CAPA plans, reviews clinical documentation, manages study audit plans, improves GxP quality systems, and supports regulatory inspections. Requires extensive clinical quality assurance experience, global clinical trial knowledge, and familiarity with FDA, ICH, and EU requirements.

Leads pharmaceutical QA compliance programs, including GxP quality systems, quality record trending, risk management, audits, regulatory inspections, product complaints, product recalls, quality metrics, and controlled document management. Partners cross-functionally with manufacturing, quality control, validation, MS&T, and vendors to identify risks, resolve recurring issues, and drive continuous improvement for commercial products.

Leads Sarepta’s commercial training and capabilities function by developing long-term training strategy, scientific and disease-state education, stakeholder communications, and innovative delivery methods. Oversees national and regional training meetings, virtual HCP engagement training, promotional review compliance, MLR submissions, consultative selling models, and program impact metrics. The role partners cross-functionally to support rare disease commercial teams and communicate complex gene therapy and RNA technology concepts.

Promotes Sarepta’s neuromuscular therapies to healthcare providers across an assigned U.S. territory. The role develops referral networks, educates providers on Duchenne muscular dystrophy treatments, genetic testing, antibody assays, access, and reimbursement, and drives enrollment and sales goals. Responsibilities include consultative selling, account planning, weekly in-person provider meetings, cross-functional collaboration, regulatory compliance, and maintaining advanced knowledge of the rare-disease treatment environment. The position requires living within the assigned geography and traveling up to 70%.

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.

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 translational biomarker strategy and implementation across nonclinical and clinical programs (emphasis on siRNA). Oversee assay development/validation, CRO/vendor management, data analysis of large omics datasets, regulatory writing, and cross-functional collaboration to support program decision-making and data dissemination.

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.