Summary:
Silverback Therapeutics, a Seattle-based biotechnology company, is seeking a highly motivated translational scientist to join our team and contribute to the preclinical and clinical development of innovative immune-modulating therapeutics. This position is responsible for designing and leading the execution of biomarker strategies to support Silverback’s drug development programs in chronic HBV, liver disease, and/or immuno-oncology. The successful candidate will be responsible for developing and implementing virology and/or immuno-oncology biomarkers guiding evaluation of drug pharmacology in clinical trials, mechanisms of action, and potential correlates of response to our novel drug candidates.
This position is preferably based in our headquarters in Seattle, WA, though a partially or fully remote position may be suitable for the right candidate.
Responsibilities:
- 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
Qualifications:
- 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
- Understanding of clinical operations and translational activities supporting clinical trials, including participation in clinical protocol, ICF, IND and/or BLA writing
- Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate (orally and in writing) complex biomarker data and their impact to program and regulatory strategy
- A detail-oriented, pro-active, enthusiastic, and goal-oriented personality
- Able to work cooperatively and independently in a fast-paced, matrixed environment
- A strong team player with ability to collaborate in cross functional teams and working closely with clinical operations, regulatory, bioinformatics, clinical pharmacology, toxicology and research colleagues, and a passion for science and helping discover and develop novel therapies for unmet medical needs
Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company leveraging our proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Our platform enables us to strategically pair linker-payloads that modulate key disease-modifying pathways with monoclonal antibodies directed to specific disease sites. Initially, we are creating a new class of targeted immuno-oncology agents that direct a myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. We are located in Seattle, Washington. To learn more, visit www.silverbacktx.com.
We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options. Qualified candidates should forward their resumes to [email protected]. We are an equal opportunity employer.
Source: Indeed.com
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