This key position contributes to the planning, design and execution of the pre and post lead translational studies using primary cells or tissue, and an array of assays based on cell and molecular biology expertise. In doing so, will also provide critical immunology expertise for the evaluation of drug candidates and their use and activity in man with the ultimate goal to treat severe diseases. The role will closely interface with both discovery and clinical teams in order to provide optimal ‘translational’ interface between discovery and patients driven studies. Specific activities include:
• Support drug discovery and early development programs by providing relevant scientific and strategic input with respect to quantitative analytics of biomarkers, PK-PD, and translational research strategy.
• Collaborate with translational biology and pharmacology colleagues to design and conduct PK/PD and/or efficacy studies to support translation and clinical dose setting
• Work with project teams to address biomarker strategy and/or biotherapeutic DMPK properties through candidate selection
• Design, execute, and report key biomarker/bioanalytical data to support compound progression and translational research strategy for programs from target loading through early clinical development
• Discover/Identify biomarker for preclinical studies and interpret experimental results
• Perform database searches to select and/or validate biomarkers
• Design assays for patient stratification and/or drug response for clinical programs
• Design, execute, interpret, and troubleshoot functional cellular immunological assays using primary human or mouse immune cells or cell lines to evaluate cellular functional activity of candidate antibodies.
• Design and perform FACS-based experiments to characterize expression and/or signaling in primary immune cells.
• Develop cellular methods to test the mechanism of action of preclinical and clinical candidates.
• Prepare internal technical reports and summaries, contribute data towards written sections for patent applications and manuscripts
• PhD in Immunology or Cell Biology (with an emphasis in Immunology) with 5+ years of experience in the biotechnology or pharmaceutical industry in biologics drug discovery research environment, preferably following a 2 year postdoctoral position.
• Ability to effectively design, execute, and troubleshoot experimental protocols to develop new methodologies.
• Possess familiarity with animal models of immune disease and be able to design both in vivo and ex vivo experiments to evaluate drug candidates.
• Current working scientific knowledge of cellular and molecular immunology with a basic understanding of antibodies
• Extensive knowledge of mammalian cell culture, including standard cell biology techniques and, working knowledge of cellular signaling and ELISA assays
• Current knowledge of the design and implementation of multi-color flow cytometry-based screening experiments
• Familiarity with preclinical models of inflammation and autoimmune disease
• Familiarity with database searches
• Experience in developing fit-for purpose biomarker/bioanalytical assays
• Experience in development of quantitative analytical bioassays from complex matrices
• Ability to identify and implement (where and when appropriate) new technologies for the advancement of quantitative biomarker analytics
• Must be able to manage assay development and analysis queues and timelines
• Knowledge of drug discovery process and pharmacology is highly desirable
• Possess outstanding communication skills, with the ability to present scientific rational, approach, results, interpretations and next steps, clearly, concisely and effectively at department and project meetings.