Scientist II - Study Director
The Study Director functions as a subject matter expert and has direct oversight to ensure successful implementation, execution, and completion of non-clinical studies. This 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 toxicology and related 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
- Participates in continual improvement initiatives
- Master's degree in related field with 5+ years of experience or PhD with 3-5 years of experience; or an equivalent combination of education and or experience in a related field
- Must have at least 2 years of experience working in a GLP environment as a study director.
- Excellent writing and communication skills
- Experience in the preparation and review of regulatory documents including authoring nonclinical modules for regulatory documents
- Highly organized and able to work with great precision and attention to detail.
- Experience with statistical and computer productivity software.
- Proven ability to manage multiple projects/tasks at one time
- Experience creating and presenting scientific presentations
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.
Apply Here: https://www.click2apply.net/QlNVYQC8rnZ2f48QSWNBn