Associate Director, Nonclinical Safety

Why Sarepta? Why Now?

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.

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness

• ​Financial Wellness

• Support for Caregivers
   

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
 

The Importance of the Role

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.

The Opportunity to Make a Difference

• 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

More about You

• 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.

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

#LI-CM1

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.

The targeted salary range for this position is $148,400 - $185,500 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.