Sarepta Therapeutics, Inc. is hiring an Associate Director, Nonclinical Safety. This role reports to the Head of Nonclinical Research Sciences and is responsible for creating and executing the nonclinical safety strategy for our therapeutic programs, ensuring they are safe and studies are conducted in a timely, budget-conscious manner.
What You'll Do
- Set the toxicology strategy for all programs and lead/manage a toxicology team.
- Design and manage nonclinical safety studies (GLP and non-GLP) suitable for IND/CTA/NDA/BLA submission.
- Manage external contract research organizations (CROs) to support nonclinical development program studies.
- Interact with other internal functional areas to ensure studies are performed in a quality, timely, and scientifically appropriate manner.
- Generate and/or review nonclinical sections for IND/CTA/BLA submissions.
- Work with external collaborators on a range of disease models.
- Participate in discussions with regulatory agencies to obtain feedback on nonclinical development programs and ensure compliance with regulatory guidelines.
- Develop and oversee nonclinical safety and toxicology drug development plans with estimated costs, timing, and risk assessment/management.
- Critically review and edit toxicology study protocols and reports, analyze and interpret data, and coordinate report finalization for both contracted and internal studies.
- Prepare and edit nonclinical documents for regulatory submissions (e.g., IND/NDA/BLA, IBs, and other regulatory briefing documents).
- Maintain a current understanding of toxicology literature and methodology, as well as scientific literature related to specific drug discovery projects.
- Maintain a current understanding of regulatory requirements and guidance.
What We're Looking For
- Ph.D., M.D., or equivalent preferably in Toxicology/Pharmacology or Veterinary Medicine.
- A minimum of 5-7 years in nonclinical development with emphasis on toxicology.
- Experience with the design, conduct, and interpretation of toxicity studies.
- Experience in IND/CTA/NDA/BLA applications.
- Experience in a research field related to Nonclinical Development, Toxicology, and Nonclinical Pharmacology.
- Familiarity with GLP requirements and ICH guidelines, experienced in management of external academic collaborations and CROs.
- Proficient in scientific documentation supporting submissions to regulatory agencies.
- Experience in the design, conduct, analysis, and interpretation of nonclinical studies.
- Training in Animal Use Protocols as PI or sponsor.
- An excellent scientific/clinical background as demonstrated through publications in medical science journals.
- Excellent verbal and written skills necessary for internal collaborations and engagement with regulatory agency bodies.
Team & Environment
You will be part of both research and development teams and an active member of the Research Strategy & Operations team, reporting to the Head of Nonclinical Research Sciences.
Benefits & Compensation
- Compensation: $148,400 - $185,500 per year.
Work Mode
This is a hybrid role based in the United States.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
