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Director – In Vivo Pharmacology
Posted on 2/17/2023
Alameda, CA, USA
Experience Level
  • Considerable experience in drug development, in vivo (NHP) study design, and scientific reporting writing
  • 8+ (B.S.), 5+ (M.S.) or 3+ (Ph.D) years' experience in drug development and in vivo pharmacology (candidates that directed IND enabling NHP studies at the contract research organizations and willing to gain drug development experience are also encouraged to apply)
  • Previous in vivo-pharmacology experience in large mammals and leading interactions with CROs (managing non-GLP and GLP-toxicology NHP studies conducted at the specialty CROs)
  • Experience in supervising GLP toxicology studies and determination of first-in-human safety doses
  • Previous experience incorporating preclinical in vivo data into regulatory filings
  • A history of authoring publications and/or study reports
  • Detail oriented, naturally seek ownership and responsibility, and excited and comfortable working in uncharted territory of gene editing
  • Comfortable in a fast-paced young biotech environment with a dynamic cross-functional team
  • Direct experience in gene therapy/editing and/or cardiovascular/liver diseases is beneficial but not necessary
  • Familiarity with CRISPR technologies and therapeutic approaches is beneficial but not necessary
  • Conceptualize, direct and oversee complex in vivo pharmacology, dose ranging, and GLP toxicology IND enabling studies in NHPs
  • Analyze in-life data, functional assessments, and ex vivo biomarker data from IND enabling nonclinical studies
  • Author and finalize study reports for regulatory filings (this work will have a direct impact on the development course of preclinical programs and will be integral for regulatory submissions)
  • Cross-functional interface with internal teams, as well as external collaborators and CROs
  • Research and propose new preclinical endpoints which can be used to support proof of concept and efficacy biology
  • Working closely with the discovery biology team to implement and execute in vivo study designs (for the IND enabling studies)
  • Prepare and organize data from preclinical in vivo studies appropriate for presentations
  • Growth mindset (with an intention to learn together and improve through iteration cycles of gene-editing drug development modalities), value transparency and camaraderie
  • Foster a driven, fast-paced, dynamic, and fun environment in which to do rigorous science
Scribe Therapeutics

11-50 employees