Why Sarepta? Why Now?
 

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
 

We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

 

The Importance of the Role

The Contract Toxicologist/Scientific Coordinator will report to the Head of Nonclinical Safety and be based in Cambridge, MA. He/She will work closely with the nonclinical safety team on various assignments to facilitate high quality deliverables that comply with regulatory and scientific best practices.

The Opportunity to Make a Difference

Assist with scientific aspects of nonclinical safety study and pathology study execution by serving as the point person for communication between nonclinical safety study directors and resource groups (e.g. the vivarium, functional outcomes, necropsy, and histology teams). Participate in project coordination and timeline/workload management activities including study  and deliverable tracking to ensure on time delivery of study deliverables and reports. Ensure timely and accurate preparation of Provantis for data collection to include review of the Provantis Protocol Definition.  For pathology-only studies in Provantis, the scientific coordinator will be responsible for study set-up.Assist in the preparation of toxicology and pathology reports and other deliverables, including setting up templates, performing informal quality control review, incorporating tables,  arranging/organizing digital images, and light desktop publishing. Assist with end of study activities including CTD table generation, SEND file review, and archival of study materials.Provides nonclinical expertise to a cross-functional study team.Works with internal functional areas to ensure all studies are performed in a high quality, timely and scientific manner.Designs protocols and ensures that the protocol and amendments are approved before work is executed.Authors, updates, and/or reviews area-specific SOP's and Protocols, ensuring that documents reflect current processesEnsures accurate documentation of study results and representation of study resultsConduct other project-related tasks with guidance as directed

More about You

Minimum of Bachelor’s Degree (BS/BA) or equivalent in biology, zoology, animal science, chemistry, pathology, or a related life sciences field.Minimum of 2 years of relevant experience in the conduct of nonclinical animal studies and/or in regulatory toxicology.Proficiency with typical corporate software, including Microsoft Word, Microsoft Excel, and Adobe Acrobat. Prior experience with of Provantis (Instem®) software is desirable but not required. Excellent verbal and written presentation and inter-personal skills.Experience in a Good Laboratory Practices (GLP) environment is desirable but not required.

What Now?
 

We’re always looking for solution-oriented, critical thinkers.

So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
 

#LI-Hybrid

This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.