Scientist, Translational Medicine
Posting Date:
Aug 11, 2021
Department at Myeloid:
Translational Immunology
Position Type:
Full-Time
Responsibilities
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Provide scientific and technical expertise in areas of biomarker discovery and development as well as mechanism of action of ATAK cells
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Lead development of the translational and biomarker strategy for all clinical programs.
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Analyze translational medicine data in support of the development of biomarkers.
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Develop clinical trial supporting, validation-ready PK, PD and immunogenicity assays to support IND enabling non-clinical studies and early phase clinical studies.
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Efficiently document method development and manage technology transfer to CROs.
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Manage CRO activities to generate critical reagents (antigens, poly-and mono-clonal antibodies, and relevant cell lines) for supporting clinical bioanalytical assays.
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Collaborate with external groups on nonclinical studies to define biomarkers of disease and potential combination strategies.
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Interface closely with Clinical Operations to operationalize translational plan and serve as subject matter expert to guide troubleshooting.
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Responsible for the translational medicine content of clinical regulatory documents including protocols, INDs, CTAs, IB, CSRs and preclinical expert reports.
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Hire, manage and mentor and develop staff to support assigned activities.
Qualification & Education
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Ph.D. or M.D./Ph.D with 5+ years of experience in translational research and biomarker development
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Direct experience in developing PD and anti-drug antibody assays in support of non-clinical and early clinical trials is required. Experience in cell therapy is ideal.
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Experience in assay development and validation in accordance with regulatory guidelines and best practices.
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Experience authoring laboratory manuals and appropriate sections of clinical documents
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A track record of successful execution of translational medicine objectives in clinical development demonstrated by abstracts, peer-reviewed publications and/or patents
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Collaborative and comfortable working as part of a cross-functional tea
Skills
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Excellent written and verbal communication skills
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Ability to think strategically
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Ability to proactively predict issues and solve problem
Knowledge
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GMP/GLP/GCP
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Regional/global regulatory requirements for biomarkers
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Emerging research in immuno-oncology