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Spark Therapeutics, Inc
Posted on Sep 1
Individual with strong pharmacology and toxicology experience in developing AAV-based therapies. The candidate will be responsible for the strategy and execution of pharmacology and toxicology studies and regulatory submissions related to Spark’s Ocular programs. The candidate will be responsible for generating the pharmacology and toxicology data required to support all phases of global development including: studies to support drug candidate optimization and selection, generation of pharmacology/toxicology data packages to support regulatory submissions, as well as the data required to understand the performance of products in the clinical setting. The ideal candidate will be an experienced scientist with strong problem solving and critical thinking abilities, and a self-starter with excellent management capabilities who is seeking to be part of an innovative team to support the company’s drug development process.
Design and manage nonclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including pharmacology, pharmacokinetics and toxicology studies.
Direct internal and extramural toxicology and pharmacology studies. Provide critical review, analysis and interpretation of data in preparation for final reports. Ensure regulatory submission and compliance.
Assume responsibility for draft, edit and finalization of nonclinical study and technical reports and nonclinical sections for IND and BLA submissions, as well as required reports for maintenance of applications to ensure regulatory compliance.
Participate in discussions with regulatory authorities to obtain feedback and respond to inquiries related to nonclinical development.
Maintain a current understanding of gene therapy literature and methodology, as well as the scientific literature related to the specific drug discovery projects.
Perform quality control checks on non-clinical pharmacology and toxicology documents for regulatory submission.
Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensure budgets, schedules, and performance requirements are met.
Responsible for all projects assigned to the organizational unit. Act as an advisor to subordinates and staff members to meet schedules or resolve technical or operational problems. Participate directly in establishing and administering many centralized functional projects. Develop and administer budgets, schedules, and performance standards.
Exert influence in the development of overall objectives and long-range goals of the organization.
Ph.D. in Toxicology or Biological Sciences with more than 5 years of post-graduate experience in pharmacology and toxicology, as related to the development of gene therapies and biologics.
Required experience in preparing/reviewing INDs (BLA/NDAs, a plus).
Experience responding to regulatory questions related to pharmacology, pharmacokinetics and toxicology.
Understanding of CMC, QA, regulatory and clinical functions to guide nonclinical activities setting up products for success at all stages of development.
Ability to synthesize and interpret diverse, multidisciplinary data sets
Experience in designing and interpreting nonclinical safety studies
Strong knowledge of pre-clinical drug development and FDA and ICH guidance documents including GLP regulations for nonclinical studies with biologics is essential
Experience evaluating the pharmacokinetic properties of biologics is a plus.
Strong written and verbal communication skills and the ability to work in a fast paced environment.
Demonstrated ability to make sound decisions and wise choices after careful consideration of various courses of action.
WHO WE ARE:
Transforming Patient’s Lives.
Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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