Sarepta Therapeutics Job Trends

The Senior Manager, Medical Operations & Platform Management is an operational leader within Global Medical Affairs (GMA), responsible for driving operational excellence across International Engagement and RNA therapies. This role will help lay the operational foundation for future expansion of Medical Affairs platforms, requiring scalable processes that can support increasing scientific complexity across Sarepta’s evolving pipeline. This role oversees planning, execution, and governance of key initiatives. The Senior Manager will partner with cross-functional teams to optimize processes, manage resources, and support the delivery of high-quality outputs that support Sarepta’s mission and scientific engagement strategy. The Senior Manager reports to the...

The Senior Manager, Quality Assurance Operations will lead the quality operations for clinical and commercial sterile drug product related to CMOs. This includes oversight of contract manufacturing and contract labs to ensure a robust and compliant quality program. The position will oversee the drug product batch record review and disposition process. The position will encompass various tasks including, but not limited to the following Establishes operational objectives, which are reviewed by senior management, and delegates assignments to subordinates. Involved in developing, modifying and executing company policies that affect immediate operations, and may also have company-wide effect. Conducts...

We are seeking a seasoned IT Validation/Quality Assurance professional with life sciences expertise to join our team as Associate Director, IT Validation. Reporting to the Director, IT Compliance and Processes, in this role, you will lead CSV/CSA activities and ensure that GxP computerized systems across R&D and Technical Operations are implemented, validated, and maintained in compliance with FDA, EMA, ICH, GAMP and other Health Authority requirements, good data integrity and data quality standards and industry guidelines/best practices. You will provide validation oversight as well as hands-on development of the computer system validation/computer software assurance lifecycle and associated deliverables from design...

The Director, Commercial Training & Capabilities will lead the development of the commercial field training function, including development of a Commercial Training strategy. The Director will also create and deliver scientific, product, and disease-state educational resources across the organization, to enhance the scientific knowledge throughout Sarepta. Familiarity with the promotional review process for training materials and the ability to communicate and train on complex medical topics will be important. This position will report to the Vice President., Opinion Leader Programming, Assay Strategy, Commercial Training & Development, Diagnostics & Bioinformatics The Opportunity to Make a Difference Build out a long-term strategic...

his role combines responsibility for overseeing Sarepta’s strategic collaborations with leadership of high-impact corporate strategy initiatives and internal consulting projects across the organization. The Opportunity to Make a Difference Sarepta Therapeutics is seeking an experienced, hands-on leader to serve as Director, Alliance Management & Corporate Strategy. This role combines responsibility for overseeing Sarepta’s strategic collaborations with leadership of high-impact corporate strategy initiatives and internal consulting projects across the organization. Reporting to the Corporate Strategy organization, this is a highly visible role with significant exposure to senior leadership and cross-functional teams. The Director will play a critical role in shaping Sarepta’s...

HPLC and Mass Spectrometry trained individual with 10+ years experience in regulated environment. Previous management of a team >5 members is required The Opportunity to Make a Difference The Senior Director will oversee the development of HPLC and Mass spectrometry based analytical methods for RNA (Phosphorodiamidate Morpholino Oligomer and Silencing RNA) Drug substance, Drug Product including in-process, release and stability testing. The individual will direct and manage the activities related to mass spectrometry based protein analysis for the AAV based product line and ADC (siRNA) programs. The person would oversee the activities in developing purity and impurity characterization methods and...

The Lead Data Manager, Clinical Data Management is responsible for providing data management expertise, process leadership, and vendor oversight for several studies within a clinical program. The selected candidate will oversee all data management activities across multiple studies; from planning, to start-up, conduct, closeout, and archiving. The candidate will maintain a high level of data quality by ensuring thoughtful and cross-functional review of eCRFs and data structure, corresponding edit checks, and collaboration to create program wide data review and cleaning strategies. The selected candidate will assist in the creation, implementation, and continued improvement of internal and external clinical data management...