Senior/Principal Scientist, Preclinical Development

Menlo Park, CA 94025

Posted: 09/18/2018 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 13887

Senior/Principal Scientist, Preclinical

  Essential duties and responsibilities include but are not limited to the following:
  • Write and edit preclinical study reports
  • Work closely with the members of Preclinical Development to evaluate therapeutic candidates in normal and ocular diseased models
  • Design and manage preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including pharmacology, toxicology, and biodistribution/shedding studies
  • Monitor conduct of preclinical study with CROs
  • Write preclinical sections for preclinical submissions
  • Work closely with other functional areas and colleagues to insure that all studies are performed in a quality, timely and scientific manner
  • Collaborate with project team members on development strategy
  • Develop, and write, position papers on safety, pharmacology and mode of action to support product development
  • Develop safety-related issue mitigation or resolution plans and coordinate execution of the experimental plan as required
  • Prepare and edit non-clinical documents for regulatory submission (e.g. IBs, and regulatory briefing documents)
  • Maintains a current understanding of pharmacology and toxicology literature and methodology, as well as the scientific literature related to the specific drug discovery projects
  • The Scientist will report directly to the Head ofPreclinical Development

 Position Requirements and Experience:
  • Ph.D. in Biological Sciences, Toxicology, Pharmacology
  • 6-8 years drug development experience, with minimum 3 years working in industrial pharmaceutical toxicology/safety assessment drug development
  • Proven experience in design, coordination, analysis and documentation of preclinical studies
  • Ability to synthesize and interpret diverse, multidisciplinary data sets
  • Extensive knowledge/understanding of pharmacology pathways and MoAs relating to the IND-enablement of biologic programs with preference given to gene therapy programs
  • Excellent scientific writing and editing as well as written/oral communication skills with several years of professional experience in medical or scientific writing
  • The ability to work independently and to collaborate with a multi-disciplined group in a goal- and team- oriented setting is required
  • Proficiency with MS Office and common laboratory software (GraphPad Prism, etc.).

Jesse Ashworth

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