SystImmune Inc.
Senior scientist, Clinic Pathology and CDx (IHC Focus)
SystImmune Inc., Redmond, Washington, United States, 98052
Senior Scientist, Clinic Pathology and CDx (IHC Focus)
Redmond, WA
SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA, specializing in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications.Job Summary:
SystImmune's Clinic Pathology and Companion Diagnostics Business (CDx) is looking for a talented and dedicated biologist to join our Clinic Pathology, CDx Research and Development team. You will define the clinical requirements for new diagnostic products, lead the clinical biomarker development and validation strategy, and contribute to driving exploratory research towards novel product opportunities including digital clinical decision support. The successful candidate will be responsible for conducting experiments, analyzing data, and contributing to the overall success of our clinical trial programs. This position requires expertise in IHC methodologies, as well as experience working in CLIA-certified laboratory environments.Key Responsibilities:
Lead the design and development of IHC-based companion diagnostic assays to detect and quantify biomarkers for patient stratification and treatment response monitoring.Lead feasibility assessments and assay optimization studies to select and validate biomarkers for inclusion in IHC-based companion diagnostic assays.Establish and validate analytical performance characteristics of IHC assays in accordance with regulatory guidelines (FDA, EMA).Maintain accurate records of experimental procedures and results in compliance with regulatory requirements.Collaborate with cross-functional teams to define biomarker strategies and integrate companion diagnostics into clinical trial protocols.Generate technical documentation to support companion diagnostic development and regulatory approval.Implement quality control procedures and participate in laboratory inspections and audits.Stay current with scientific literature and emerging technologies in the field of immunohistochemistry.Drive the execution of the global clinical diagnostic strategy for therapeutic programs in early and late-stage clinical development.Qualifications:
Ph.D. or M.S. in Biological Sciences, Pathology, Immunology or related field with relevant experience in clinical research or diagnostic laboratory settings.Demonstrated expertise in immunohistochemistry techniques.Experience working in CLIA-certified laboratories and familiarity with CLIA regulations.Strong analytical skills with the ability to interpret complex experimental data.Excellent organizational skills and attention to detail.Effective communication and interpersonal skills.Proficiency in relevant software tools for data analysis and image quantification.Prior experience with biomarker discovery or companion diagnostics development is desirable.Passionate about working at the intersection of digital pathology and AI.The hiring pay range for this position is $120,000 - $180,000 per year based on skills, education, and experience relevant to the role.SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match of up to 3%, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to hr@systimmune.com
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Redmond, WA
SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA, specializing in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications.Job Summary:
SystImmune's Clinic Pathology and Companion Diagnostics Business (CDx) is looking for a talented and dedicated biologist to join our Clinic Pathology, CDx Research and Development team. You will define the clinical requirements for new diagnostic products, lead the clinical biomarker development and validation strategy, and contribute to driving exploratory research towards novel product opportunities including digital clinical decision support. The successful candidate will be responsible for conducting experiments, analyzing data, and contributing to the overall success of our clinical trial programs. This position requires expertise in IHC methodologies, as well as experience working in CLIA-certified laboratory environments.Key Responsibilities:
Lead the design and development of IHC-based companion diagnostic assays to detect and quantify biomarkers for patient stratification and treatment response monitoring.Lead feasibility assessments and assay optimization studies to select and validate biomarkers for inclusion in IHC-based companion diagnostic assays.Establish and validate analytical performance characteristics of IHC assays in accordance with regulatory guidelines (FDA, EMA).Maintain accurate records of experimental procedures and results in compliance with regulatory requirements.Collaborate with cross-functional teams to define biomarker strategies and integrate companion diagnostics into clinical trial protocols.Generate technical documentation to support companion diagnostic development and regulatory approval.Implement quality control procedures and participate in laboratory inspections and audits.Stay current with scientific literature and emerging technologies in the field of immunohistochemistry.Drive the execution of the global clinical diagnostic strategy for therapeutic programs in early and late-stage clinical development.Qualifications:
Ph.D. or M.S. in Biological Sciences, Pathology, Immunology or related field with relevant experience in clinical research or diagnostic laboratory settings.Demonstrated expertise in immunohistochemistry techniques.Experience working in CLIA-certified laboratories and familiarity with CLIA regulations.Strong analytical skills with the ability to interpret complex experimental data.Excellent organizational skills and attention to detail.Effective communication and interpersonal skills.Proficiency in relevant software tools for data analysis and image quantification.Prior experience with biomarker discovery or companion diagnostics development is desirable.Passionate about working at the intersection of digital pathology and AI.The hiring pay range for this position is $120,000 - $180,000 per year based on skills, education, and experience relevant to the role.SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match of up to 3%, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to hr@systimmune.com
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