Associate Director, Nonclinical Safety

Columbus, NE - USA

Yearly Salary: $ 148400 - 185500

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were 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: 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
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.
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

Were always looking for solution-oriented critical thinkers.

So if youre 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 Sareptas 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 $148400 - $185500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas 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.

Required Experience:

Director

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 2023 we launched our fourth thera...

Why Sarepta Why Now

Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

Physical and Emotional Wellness
Financial Wellness
Support for Caregivers

For a full list of our comprehensive benefits see our website: Importance of the Role

The Opportunity to Make a Difference

Sets the toxicology strategy for all programs
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.
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

Were always looking for solution-oriented critical thinkers.

So if youre 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 Sareptas facilities in the United States and/or attend Company-sponsored in-person events from time to time.

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.

Required Experience:

Director

Key Skills

Program assessment
FDA Regulations
Manufacturing & Controls
Program Evaluation
budget forecast
Research Experience
Operations Management
Research & Development
Strategic Planning
Contract Management
Leadership Experience
negotiation

Apply Now

About Company

Sarepta Therapeutics

We are focused on the development of precision genetic medicines to treat rare neuromuscular and central nervous system diseases. Learn more about Sarepta.

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