Biomarker Lead: Associate Director/Director, Translational Pharmacology
Responsible for strategic planning and execution of Translational Pharmacology efforts related to the development of investigational, CRISPR gene-edited cell therapies. This position reports in to the Clinical Biomarkers and Exploratory Research group within Translational Pharmacology. Candidate 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.
• Setting clinical biomarker and exploratory translational strategies for CRISPR candidate therapeutics
• Collaborate with discovery/pre-clinical scientists, clinical assays development team, and clinical scientist/medical director
• 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
• Collaborate with clinical operations and clinical assay operations to define sample journey and develop appropriate clinical laboratory manuals
• Manage vendor and CRO relationships for sample analysis
• Contribute to the development of 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).
• 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
• 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
• 7+ 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
- 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 # 2018-408 in the subject line when emailing resume to: firstname.lastname@example.org.
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.