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Manager/Senior Manager - Clinical Assay Lead

Company: CRISPR Therapeutics
Location: Cambridge
Posted on: January 8, 2021

Job Description:

Job SummaryCRISPR Therapeutics is seeking a Clinical Assay Lead to join us in developing novel gene editing therapies for serious diseases. This position will report into the Translational Pharmacology Department, within a Clinical Assay Group. The successful candidate will have the opportunity to manage a portfolio of assays required to execute clinical trials. This includes translating the needs of the clinical program into a portfolio of assays, liaising with SMEs for technical development of assays, responsibility of CRO management and ensuring timely data delivery in support of clinical trials. This position requires knowledge of GxP-like method qualification and GxP-quality level method validation, and associated documentation in support of regulatory submissions. Your broad and wide-ranging experience in managing clinical trials and/or bioanalytical activities will create engagement and impact for the right candidate. The desired candidate will demonstrate enthusiasm, passion, attention to detail, and a desire to create important new medicines for patients.Responsibilities

  • Develop a portfolio of clinical assays and vendor strategies for CRISPR candidate therapeutics via collaboration with discovery/pre-clinical scientists, translational scientists, biomarker leads, clinical scientists and commercial vendors
  • Propose and manage the development of assays appropriate for programmatic advancement decisions
  • Collaborate with clinical operations and clinical sample operations to inform domestic and international sample journey plans and contribute to appropriate clinical laboratory manuals
  • Work with clinical data management and biometrics to ensure appropriate and timely transfer of data
  • Manage vendor and CRO relationships for assay development, transfer, validation and clinical sample analysis
  • Ensure that assay validation and sample analyses are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, EMA, CHMP, WHO, GLP, and ISO).
  • Contribute to creation of standards in this new field of gene-editing based therapies
  • Ensure quality and timely submission of all clinical-related documents and materials for regulatory filings (such as development/validation reports, SOPs, sample analyses reports) and also contribute as necessary to IND, CTA, meeting briefing books, or other requests from global regulatory authorities.
  • Monitor GLP/GCLP quality level method validation of assays at CROs by providing technical expertise and troubleshooting, as needed, and review of documents for multiple clinical projects simultaneously
  • Manage critical project and program deadlines
  • Effectively communicate results, project progress and technical challenges to all appropriate team membersMinimum Qualifications
    • BS or MS with 3 years or PhD with 1 years of experience in Clinical Trial Management and/or Bioanalytical Assay Development/Validation in support of toxicology and clinical trial activities for early and late stage therapeutic programs
    • Working knowledge of bioanalytical techniques, assay development and validation
    • Working knowledge of the principles of clinical trial operations
    • Prior experience working in a biotechnology or pharmaceutical company coordinating and managing external projects at CROs within tight timelines
    • Excellent oral and written communication skills
    • Ability to work independently as well as collaborate with peers and effectively work in a fast-paced and cross-functional results-oriented team environment
    • Ability to work within tight timelines for successful and timely execution of project and program goals
    • Financial management of projects, including on-time and on-budget deliverables
    • Ability to travel, if required (Approximately 10%)Preferred Qualifications
      • MS degree or higher degree with 5 years of experience in clinical drug development
      • Working knowledge of assay development and validation of molecular biology techniques including, but not limited to, quantitative PCR (qPCR), and DNA Sequencing (NGS) techniques
      • Working knowledge of assay development and validation of protein biology assays, such as HPLC, ELISA, MSD and Luminex
      • Working knowledge of assay development and validation of immunological techniques including multi-parameter flow cytometry and immunohistochemistry
      • Experience working in CAR-T cell or gene therapies
      • Experience in authoring and reviewing regulatory documentation for GLP or GCLP quality level projects
      • Detailed knowledge of cellular and tumor immunology principles
      • Basic knowledge of gene editing and CRISPR based technologyCRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.To view our Privacy Statement, please click the following link: by JazzHR9kO5242JJe

Keywords: CRISPR Therapeutics, Cambridge , Manager/Senior Manager - Clinical Assay Lead, Executive , Cambridge, Massachusetts

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