Jobs at Sarepta Therapeutics

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 development of commercial field training strategy and capabilities, create and deliver scientific, product, and disease-state education, ensure promotional review/MLR compliance, implement virtual and in-person training delivery (national/regional), measure training impact, and collaborate cross-functionally to meet business needs.

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 Data Manager manages clinical data management activities across studies, ensuring data quality and compliance while collaborating with cross-functional teams and vendors.

The Director, Market Access Marketing leads the development and execution of US reimbursement and payer access strategies, ensuring optimal product positioning across payers. This role involves collaboration with cross-functional teams and oversight of promotional materials while managing a budget and a marketing team.

The Director of Analytical Development will lead the advancement of analytical methods for siRNA and antisense oligonucleotides, manage external manufacturing site activities, and oversee regulatory submissions while mentoring a team of scientists.

Responsible for inventory and manufacturing cost accounting: prepare journal entries, reconcile general ledger and inventory accounts, support audits, develop standard costs, analyze variances, assist with physical counts, maintain SOX controls, and improve processes across supply chain and manufacturing operations.

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 commercial reporting and operations for Commercial organization: build and maintain dashboards and Executive reports, manage contracted analysts, administer Tableau, partner with cross-functional teams (Sales Effectiveness, Patient Services, Data Management, Site Readiness), set reporting standards, manage delivery schedules, and support Veeva/CRM alignment and data stewardship.

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.

The Duchenne Nurse Educator educates healthcare providers, patients, and caregivers about Duchenne muscular dystrophy and infusion processes, ensuring support for medication compliance and conducting on-call triage support as needed.

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.

Lead clinical pharmacology strategies and manage a team in drug development. Oversee translational and mechanistic modeling to inform clinical development.

The Associate Director, Quantitative Clinical Pharmacology drives quantitative strategies and pharmacometrics analyses for drug development and regulatory strategies, requiring strong expertise in clinical pharmacology and PK/PD modeling.

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

The Associate Director will lead the strategy for study start-up and feasibility in clinical operations, overseeing activities and timelines for clinical trials while collaborating with teams and vendors.

The Senior Scientist will assess developability of lead biologic molecules through evaluation and characterization, collaborating across teams to define attributes and stability assays.

Design and develop global clinical drug supply operations, translating program requirements into compliant, timely supply chain plans; optimize packaging, labeling, distribution, inventory positioning, and temperature-controlled logistics; lead continuous improvement, process mapping, capacity planning, KPI dashboards, investigations, and CMO/vendor project management.