Sarepta Therapeutics
Teams at Sarepta Therapeutics
Recently posted jobs
5 Days AgoSaved
Biotech
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.
Biotech
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.
Biotech
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.
