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 

• Lead development of the translational and biomarker strategy for all clinical programs.

• Analyze translational medicine data in support of the development of biomarkers.

• Develop clinical trial supporting, validation-ready PK, PD and immunogenicity assays to support IND enabling non-clinical studies and early phase clinical studies.

• Efficiently document method development and manage technology transfer to CROs.

• Manage CRO activities to generate critical reagents (antigens, poly-and mono-clonal antibodies, and relevant cell lines) for supporting clinical bioanalytical assays.

• Collaborate with external groups on nonclinical studies to define biomarkers of disease and potential combination strategies.

• Interface closely with Clinical Operations to operationalize translational plan and serve as subject matter expert to guide troubleshooting.

• Responsible for the translational medicine content of clinical regulatory documents including protocols, INDs, CTAs, IB, CSRs and preclinical expert reports.

• 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

• 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. 

• Experience in assay development and validation in accordance with regulatory guidelines and best practices.

• Experience authoring laboratory manuals and appropriate sections of clinical documents 

• A track record of successful execution of translational medicine objectives in clinical development demonstrated by abstracts, peer-reviewed publications and/or patents 

• Collaborative and comfortable working as part of a cross-functional tea

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Skills

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• Excellent written and verbal communication skills 

• Ability to think strategically

• Ability to proactively predict issues and solve problem

 

Knowledge

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• GMP/GLP/GCP

• Regional/global regulatory requirements for biomarkers

• Emerging research in immuno-oncology