Associate Director, Nonclinical Safety

Sarepta Therapeutics Inc.•Columbus, OH

69d•Hybrid

About The Position

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. 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 Associate Director will report to the Head of Nonclinical Research Sciences and will be responsible for the creation and execution of the nonclinical safety strategy for our therapeutic programs, both research and clinical stage, ensuring therapeutics are safe and studies are conducted a timely manner, within budget & scope. This role will be a part of both research and development teams and will be an active member of the Research Strategy & Operations team.

Requirements

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 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.
Successful track record of leading and mentoring employees at various levels.
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.
Candidates must be authorized to work in the U.S.

Responsibilities

Sets the toxicology strategy for all programs
Leads/manages a toxicology team
Designs and manages nonclinical safety studies (GLP and non-GLP) suitable for IND/CTA/NDA/BLA submission
Manages external contract research organization (CROs) to support nonclinical development program studies
Interacts with other internal functional areas to ensure that studies are performed in a quality, timely, and scientifically appropriate manner
Generates and/or reviews nonclinical sections for IND/CTA/BLA submission
Works with external collaborators on a range of disease models
Participates in discussions with regulatory agencies to obtain feedback on nonclinical development programs
Ensures compliance with regulatory guidelines
Develops and oversees nonclinical safety and toxicology drug development plans with estimated costs, timing, and risk assessment/management
Critically reviews and edits toxicology study protocols and reports, analyzes and interprets data, and coordinates report finalization for both contracted and internal studies
Prepares and edits nonclinical documents for regulatory submissions (e.g. IND/NDA/BLA, IBs, and other regulatory briefing documents)
Maintains a current understanding of toxicology literature and methodology, as well as scientific literature related to the specific drug discovery projects
Maintains a current understanding of regulatory requirements and guidance
Quarterly travel may be required