The Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA working within a CMC sub team structure and serving as a member of the GRT. The Senior Manager will a

The Manager, Medical Reviewer provides operational oversight of medical materials review within the Medical Affairs function reporting to the Director of Global Medical Review. This individual works closely and effectively with key members of internal departments including Marketing, Legal/Compliance, Regulatory, Medical Affairs and Clinical Development to assure that all

The Real World Evidence (RWE) Contract Epidemiologist will provide leadership for scientific prospective and retrospective activities in the RWE team supporting Sarepta. The RWE Contract Epidemiologist will function in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Qu

Sarepta Therapeutics is looking for an energetic and resourceful HR Informations Systems Technical Analyst. As an HRIS IT Technical Analyst, you will play a crucial role in supporting and optimizing our Human Resource Information System (HRIS), with a specific focus on Workday. Your expertise will be essential in ensuring smooth system operations, data integrity, and effec

The Scientist I, Bioinformatics works closely with several groups within Sarepta's Research and Development department. The Scientist I, Bioinformatics is part of the Genomics and Data Sciences team and plays a critical role in supporting Discovery Biology to advance our portfolio of RNA, gene therapy, and CRISPR based gene editing therapies to treat neuromuscular and CNS

The Associate Director, Commercial Diagnostics & Bioinformatics reports into the Executive Director, Commercial Diagnostics and plays a key role in driving the strategic vision and objectives to make Sarepta a recognized leader in precision genetic medicine for rare diseases. The Associate Director, Commercial Diagnostics analyzes genetic diagnostic data to provide insight

This individual will work with cross functional teams to advance transformative precision genetic medicines for people with Duchenne muscular dystrophy (DMD). The ideal candidate must be able to lead a Biometrics team comprising biostatisticians and statistical programmers and excel as a hands on innovative biostatistician. He/she will be a strategic thinker, a good commun

The Senior Director, Global Market Access Strategy (GMAX) drives market access strategy for Sarepta's assets with influential leadership that represent the goals and priorities of the broader International Business Unit to cross functional teams such as the Global Product Team (GPT) or Customer Org Sub Team (CT). This role is responsible for developing market access and ev

The Senior Manager will prepare and develop translational and clinical pharmacology plans including dose selections and predictions using mathematical and statistical models to study complex interactions between drugs, patients, and biological systems to understand disease progression and the impact of patient stratification on disease progression and pharmacology. This ro

The Real World Evidence (RWE) lead provides clinical leadership for evidence generation activities, supporting the integration of RWE into Sarepta key strategic initiatives. The role functions in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufa

The Manager, Forecasting will be responsible for supporting commercial forecast development to support the commercial success of Sarepta's current platform and other pipeline products. This position will partner with key stakeholders (Competitive Intelligence teams, Market Access, Sales, Patient Services, Finance, International Business, etc.) to ensure development of robu

Co lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs) for assigned projects. Positively contributes to the regulatory probability of su

The Manager, Data Governance & Analytics assists in leading a data driven approach to support key strategic initiatives that ensure the launch and commercial success of Sarepta's current platform and pipeline products. This position partners with several Customer teams to ensure effective and impactful leverage of analytics initiatives. This role partners with Field Analyt

The MSL will play a pivotal role in the education of healthcare professionals (HCPs) about Duchenne Muscular Dystrophy and Limb Girdle Muscular Dystrophy as well as Sarepta's investigational therapeutics and product pipeline. Reporting to the East Region Team Leader, the MSL position will play a pivotal role in the education of healthcare professionals (HCPs) about Duchenn

The Vice President of CMC Management is a senior leadership position within Technical Operations that will lead a team of CMC leads and CMC project managers and will be accountable for ensuring that the team provides effective CMC oversight to support product development. The VP will monitor and address all risks and challenges with their staff and ensure continuous awaren