Participate in the development of translational strategies, in collaboration with other functional experts, for the discovery, development and implementation of biomarkers in clinical trials to support indication selection, demonstrate pharmacologic/pharmacodynamic effects, characterize dose-response relationships, investigate mechanisms of action, and evaluate patient or disease factors that correlate with therapeutic response.
Lead internal and outsourced development and qualification or validation of biomarker assays for clinical trials, applying experience across multiple methods (e.g., flow cytometry, immunohistochemistry, soluble biomarker assays, PCR) to develop robust assays, generate and analyze data and provide expert interpretation of the effects of promising drug candidates on the immune system and disease biology.
Collaborate with Research, Clinical and Development Sciences functions to create synergy in developing and implementing biomarker strategies and translational approaches.
Collaborate on cross-functional teams (e.g., with clinical development and clinical operations, bioanalytical scientists, bioinformaticians) and oversee external partners / contract labs to ensure successful operational execution of biomarker plans.
Author relevant sections of regulatory documents (e.g., INDs, briefing documents, clinical protocols, clinical study reports).
Communicate data and strategies effectively to internal project teams, senior management, and external partners/organizations.
Establish and maintain collaborative relationships with internal and external functional experts that can contribute to the translational strategy, identify, and manage relevant external collaborations to HBV / liver disease cure. Build strong internal expertise in HBV / liver disease models and biomarkers supportive of development of cures.
Ph.D. or MD/DVM/PhD in Immunology, Virology, Oncology, Cell Biology, or a related field.
3-5+ years of biotech/pharmaceutical drug discovery and development experience, with experience serving as the biomarker lead on project teams for clinical-stage hepatitis, liver-disease, oncology and/or immuno-oncology programs at a pharmaceutical or biotech company.
Strong experimental background and experience in hypothesis-driven translational research with ability to execute well-designed translational plans in clinical trials.
Good understanding of and experience in translating disease biology and the pharmacology of drug candidates into clinical biomarker strategies that efficiently address key questions during clinical development and impact clinical decision-making.
Experience applying molecular, cellular, and imaging technologies in clinical trials to demonstrate drug pharmacology and inform patient selection strategies; expertise in HBV molecular assays and flow cytometry preferred.
Experience with development, qualification, validation, and execution of biomarkers assays (such as soluble markers, flow cytometry, IHC, PCR, genomic profiling) with 3rd party vendors and contract laboratories.