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(Associate Director) Clinical Biomarkers (Immunologist)

Job Overview:

Major Responsibilities and Duties:

• Primary accountability for developing indication selection and translational biomarker strategies in collaboration with Research and Clinical Teams that assess proof of target engagement, and/or pharmacodynamics activity, establish early signs of efficacy, enabling proof of concept studies, and understanding disease progression
• Partner with drug discovery scientists to design and execute translational research to discover and validate pathways and biomarkers associated with mechanism of action and drug response.
• Providing key biological validation by leveraging insight gained from patient-derived functional, genetic, and biochemical biomarkers.
• Consults with project teams on biomarker discovery, pre-strategic assessment of indications for clinical samples profiling and understanding of mechanisms or disease related biology
• Collaborates with research and clinical colleagues to develop scientifically rigorous translational and exploratory biomarker strategies that assess proof of mechanism, establish early signs of efficacy, enable proof of concept studies, and generate an understanding of the variability in patient response

Responsibilities and Duties:

Qualifications:

• Advanced science degree (PhD) with 3 or more years of related experience focused on immunology.
• Minimum of 2 years of hands-on expertise developing and executing preclinical studies/assays.
• Demonstrated knowledge of designing, implementing and conducting studies for biomarker discovery, validation, and qualification using human biomaterials to produce both timely and good quality data.
• Strong communication skills (oral, written, and presentations).
• Up-to-date working knowledge and understanding of regulatory and quality guidance and requirements related to the general principles for development and validation of assays for biological products.
• Ability to operate independently with minimal supervision

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