Principal Scientist, Nonclinical Safety

The Principal Scientist functions as a subject matter expert and has direct oversight to ensure successful implementation, execution, and completion of non-clinical studies. The individual filling this position must have extensive Good Laboratory Practice (GLP) experience and must be able to influence best practices. The Study Director will assume the responsibility for the technical conduct of a particular study as well as the interpretation, analysis, documentation and reporting of study results.

Primary Responsibilities Include:

Serves as Study Director on GLP and nonGLP toxicology studies and oversees all technical and scientific study conduct and deliverables through study completion.

Ensures all applicable GLP standards/ regulatory (FDA 21 CFR Part 58) are followed.

Assures adequate test materials and test systems are available.

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.

Disseminates notifications of study, protocol, and amendments/deviations to study personnel and QAU

Authors, updates, and/or reviews area-specific SOP's and Protocols, ensuring that documents reflect current processes

Ensures accurate documentation of study results and representation of study results

Ensures archival of data in a timely manner

Leads/participates in continual improvement initiatives

May take on other tasks/initiatives identified by management as appropriate

Desired Education and Skills:

BS/BA, MS/MA, or PhD in relevant scientific discipline with 15+, 12+, or 9+ years of related experience, respectively

Must have at least 5 years of experience working in a GLP environment in the biopharmaceutical industry as a Study Director

Must be proactive, collaborative, responsive, and diligent

Excellent communication (verbal, written, and presentation) and people skills

Ability to adapt to a fast-paced and dynamic biotech environment and overcome challenges with a positive “can-do” attitude

Willingness to learn and contribute

Highly organized and able to work with great precision and attention to detail

Experience with statistical and computer productivity software (eg Provantis)

Proven ability to manage multiple projects/tasks at one time

#LI-Onsite

This position requires work on site at one of Sarepta’s facilities in the United States.

The targeted salary range for this position is $133,200 - $166,500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

R-02466