Tbwa Chiat/Day Inc
Associate Director/Director, Translational Biomarkers Bothell, Washington, Unite
Tbwa Chiat/Day Inc, Bothell, Washington, United States, 98021
Associate Director/Director, Translational Biomarkers
Bothell, Washington, United States Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) Our pipeline includes AL102, a gamma secretase inhibitor currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. Position Overview The Associate Director/Director, Translational Biomarkers will be responsible for clinical biomarker activities to support Immunome’s drug development programs in oncology. This individual will assume biomarker lead responsibilities such as serving as biomarker representative on study teams, setting up biomarker plans for individual trials and ensuring appropriate collection and timely analysis and reporting of final biomarker data. They will ensure appropriate data analysis and interpretation to support decision-making for clinical-stage programs. The successful candidate will have prior oncology clinical experience in biotech/pharma organizations, including interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists. This role reports to the Executive Director, Translational Biomarkers. Responsibilities Designs and implements program-specific early and late development biomarker plans Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation Directs the development, outsourcing and validation of clinically applicable companion diagnostic assays for Phase 1 through registrational studies Provides expertise to development project teams to ensure access to state-of-the-art thinking on appropriate diagnostic technologies, evaluating their scientific basis and clinical applicability Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs Responsible for aiding in the creation of clinical protocols, SAPs, SOWs, lab manuals, and interfacing with CROs for execution of services Prepares and delivers internal and external translational biomarker presentations Keeps up-to-date on relevant scientific/technical literature and technologies to apply external knowledge to internal biomarker and companion diagnostic development Participates in post-hoc biomarker analysis and publication efforts Supports regulatory submissions and regulatory interactions as needed Requirements/Qualifications Bachelor’s, Master’s, or Ph.D degree in a Life Sciences field A minimum of 12 years of industry experience (or 10+ years with a Master's degree, or 8+ years with a doctoral degree) in clinical biomarkers Experience with immunohistochemistry (IHC) assay development and validation Experience in clinical oncology biomarkers and diagnostics as well as awareness of the challenges of implementing diagnostic technologies in the clinical setting Skills/Knowledge Required Experience with developing, leading, and executing translational biomarker strategies Experience with establishing robust validation plans and executing validation studies to demonstrate the clinical utility, analytical validity, and reproducibility of biomarkers Demonstrated experience supporting clinical development of biomarkers and companion diagnostics Excellent problem-solving skills and ability to oversee multiple projects simultaneously in a fast-paced environment Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly High level of initiative and ability to work independently Washington State Pay Range $162,000 - $237,000 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Bothell, Washington, United States Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) Our pipeline includes AL102, a gamma secretase inhibitor currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. Position Overview The Associate Director/Director, Translational Biomarkers will be responsible for clinical biomarker activities to support Immunome’s drug development programs in oncology. This individual will assume biomarker lead responsibilities such as serving as biomarker representative on study teams, setting up biomarker plans for individual trials and ensuring appropriate collection and timely analysis and reporting of final biomarker data. They will ensure appropriate data analysis and interpretation to support decision-making for clinical-stage programs. The successful candidate will have prior oncology clinical experience in biotech/pharma organizations, including interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists. This role reports to the Executive Director, Translational Biomarkers. Responsibilities Designs and implements program-specific early and late development biomarker plans Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation Directs the development, outsourcing and validation of clinically applicable companion diagnostic assays for Phase 1 through registrational studies Provides expertise to development project teams to ensure access to state-of-the-art thinking on appropriate diagnostic technologies, evaluating their scientific basis and clinical applicability Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs Responsible for aiding in the creation of clinical protocols, SAPs, SOWs, lab manuals, and interfacing with CROs for execution of services Prepares and delivers internal and external translational biomarker presentations Keeps up-to-date on relevant scientific/technical literature and technologies to apply external knowledge to internal biomarker and companion diagnostic development Participates in post-hoc biomarker analysis and publication efforts Supports regulatory submissions and regulatory interactions as needed Requirements/Qualifications Bachelor’s, Master’s, or Ph.D degree in a Life Sciences field A minimum of 12 years of industry experience (or 10+ years with a Master's degree, or 8+ years with a doctoral degree) in clinical biomarkers Experience with immunohistochemistry (IHC) assay development and validation Experience in clinical oncology biomarkers and diagnostics as well as awareness of the challenges of implementing diagnostic technologies in the clinical setting Skills/Knowledge Required Experience with developing, leading, and executing translational biomarker strategies Experience with establishing robust validation plans and executing validation studies to demonstrate the clinical utility, analytical validity, and reproducibility of biomarkers Demonstrated experience supporting clinical development of biomarkers and companion diagnostics Excellent problem-solving skills and ability to oversee multiple projects simultaneously in a fast-paced environment Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly High level of initiative and ability to work independently Washington State Pay Range $162,000 - $237,000 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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