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Director/Sr. Director, Translational Pharmacology

If interested and qualified, please include Requisition # 2018-337 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

Responsible for strategic planning and execution of Translational Pharmacology efforts related to the development of investigational, CRISPR gene-edited cell therapies. This person will be a core member of the drug development team and is responsible for the strategic development, documentation, and oversight of the drug candidate translational pharmacology plan. Such plans will consider both “forward translation” of developing a drug candidate from pre-clinical to clinical proof of concept as well as “reverse translation” of clinical samples and data to enrich new discovery/pre-clinical efforts. Execution of the plan will be accomplished in collaboration with others as detailed subsequently.

Responsibilities

  • Collaborate with discovery/pre-clinical scientists, clinical assays development team, and clinical scientist/medical director
  • Identify and remedy gaps relative to existing pre-IND data sets to support IND filing and clinical program
  • Consider requirements for measuring and reporting biological fate of administered cell therapies during clinical development (pharmacodynamic modeling, cell persistence/engraftment, cellular distribution, etc.)
  • Propose and develop biomarkers appropriate for programmatic advancement decisions
  • Develop and execute exploratory research plans that leverage clinical trial samples and data
  • Develop diagnostic assays for clinical development and commercialization from pre-clinical stage through drug and device approval
  • Ensure that Translational Pharmacology studies and assay sample analyses are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO, GLP, and ISO). 
  • Where appropriate, and in collaboration with Regulatory Affairs and other key stakeholders, leads and/or engages in discussions with industry groups and regulatory authorities to address opportunities to expedite the development of novel transformative gene-editing based drugs for the treatment of life-threatening conditions that may require more creative, less traditional or guideline-based approach to Translational Pharmacology aspects of drug development (while maintaining an assurance of patient safety)
  • Proactive creation of standards in this new field of gene-editing based therapies
  • Ensure quality and timely submission of all Translational Pharmacology-related documents and materials for regulatory filings, including pre-IND or scientific advice filings, IND or CTA, meeting briefing books, or other requests from global regulatory authorities
  • Provide support to multidisciplinary research project teams in areas such as genomics, DNA sequence analysis, pharmacology, and biology

Minimum Qualifications

  • Medical and/or Doctoral degree and post-doctoral training in a field related to Clinical Pharmacology, Translational Pharmacology, Pharmacogenomics or Biomarkers
  • At least 5 years of experience in a translational development-related position(s) in a biotech or pharmaceutical setting
  • A deep understanding of pre-clinical, translational, and clinical drug development
  • Experience in biomarker and/or genomic-related research in the pharmaceutical/biotech setting

Preferred Qualifications

  • 10+ years of experience in a translational development-related position(s) in a biotech or pharmaceutical setting
  • Understanding of the evolving regulatory requirements for cell and gene therapy (OTAT) products in the US or ATMP products in Europe.
  • Experience with development of Cell and Gene Therapy or ATMP products, and development requirements
  • Experience in measuring and/or modeling drug disposition
  • Experience in developing immuno-oncology therapies, including CAR T therapies

Competencies

  • Collaborative Openness, One Team
  • Undaunted – Fearless, Can-do attitude
  • Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
  • Entrepreneurial Spirit – Proactive. Ownership mindset.

If interested and qualified, please include Requisition # 2018-337 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.