CRISPR Therapeutics Manager/Senior Manager - Clinical Assay Lead in Cambridge, Massachusetts
CRISPR 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.
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 members
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%)
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 technology
CRISPR 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.
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