{"schemaVersion":"jobsearcher.job.v1","id":"8b302d959cf3efaa657d8d3f","url":"https://jobsearcher.com/jobs/8b302d959cf3efaa657d8d3f","canonicalUrl":"https://jobsearcher.com/jobs/8b302d959cf3efaa657d8d3f","title":"Director, CDx Development","description":"Job Description: Lead the development and execution of integrated CDx strategies across clinical development programs, ensuring alignment with overall drug development objectives and timelines.\r\nEngage early with Translational Discovery and Research teams to understand predictive hypotheses and biomarker strategies for pipeline programs.\r\nPartner with internal research teams and external vendors to develop predictive assays when suitable assays are not already available.\r\nDefine and advance CDx strategies through internal governance bodies, securing timely alignment and endorsement.\r\nCollaborate cross-functionally to define Diagnostic Target Product Profiles and identify optimal diagnostic platforms and CDx partners.\r\nWork closely with Regulatory Affairs to support the preparation and submission of regulatory documentation (e.g., IDEs, PMAs) and to interact with global health authorities as needed.\r\nOversee CDx development activities to ensure on-time delivery of diagnostic kits to support pharmaceutical registration and commercial launch.\r\nProvide clear, proactive communication to cross-functional stakeholders on CDx program progress, risks, and mitigation strategies.\r\nMonitor and interpret emerging industry trends, technology advancements, and evolving regulatory requirements related to IVDs and companion diagnostics.\r\nRequirements: PhD with a minimum of 5+ years of industry experience in clinical biomarker testing and companion diagnostics development\r\nStrong scientific and technical expertise in clinical development, biomarker strategies, and regulatory requirements for IVD and CDx products\r\nHands-on knowledge of diagnostic platforms such as NGS, IHC, FISH, and related technologies\r\nProven ability to lead complex, cross-functional programs to completion on time and within budget\r\nStrong analytical and strategic thinking skills, with the ability to make data-driven decisions in ambiguous or complex situations and to think at a portfolio level\r\nDemonstrated ability to influence and align stakeholders across development and commercial organizations without direct authority\r\nExcellent communication skills, with the ability to convey complex scientific and strategic concepts clearly to both technical and non-technical audiences\r\nExperience working effectively in a matrixed environment and leading cross-functional teams.\r\nBenefits: Medical\r\nDental\r\nVision\r\n401(k)\r\nFSA/HSA\r\nLife Insurance\r\nPaid Time Off\r\nWellness","company":"Remote Rocketship","rawCompany":"remoterocketship","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-05-14T03:49:26.549Z","occupations":[{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"},{"code":"11-9111.00","title":"Medical and Health Services Managers","slug":"medical-and-health-services-managers"},{"code":"19-1042.00","title":"Medical Scientists, Except Epidemiologists","slug":"medical-scientists-except-epidemiologists"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Director, CDx Development","description":"Job Description: Lead the development and execution of integrated CDx strategies across clinical development programs, ensuring alignment with overall drug development objectives and timelines.\r\nEngage early with Translational Discovery and Research teams to understand predictive hypotheses and biomarker strategies for pipeline programs.\r\nPartner with internal research teams and external vendors to develop predictive assays when suitable assays are not already available.\r\nDefine and advance CDx strategies through internal governance bodies, securing timely alignment and endorsement.\r\nCollaborate cross-functionally to define Diagnostic Target Product Profiles and identify optimal diagnostic platforms and CDx partners.\r\nWork closely with Regulatory Affairs to support the preparation and submission of regulatory documentation (e.g., IDEs, PMAs) and to interact with global health authorities as needed.\r\nOversee CDx development activities to ensure on-time delivery of diagnostic kits to support pharmaceutical registration and commercial launch.\r\nProvide clear, proactive communication to cross-functional stakeholders on CDx program progress, risks, and mitigation strategies.\r\nMonitor and interpret emerging industry trends, technology advancements, and evolving regulatory requirements related to IVDs and companion diagnostics.\r\nRequirements: PhD with a minimum of 5+ years of industry experience in clinical biomarker testing and companion diagnostics development\r\nStrong scientific and technical expertise in clinical development, biomarker strategies, and regulatory requirements for IVD and CDx products\r\nHands-on knowledge of diagnostic platforms such as NGS, IHC, FISH, and related technologies\r\nProven ability to lead complex, cross-functional programs to completion on time and within budget\r\nStrong analytical and strategic thinking skills, with the ability to make data-driven decisions in ambiguous or complex situations and to think at a portfolio level\r\nDemonstrated ability to influence and align stakeholders across development and commercial organizations without direct authority\r\nExcellent communication skills, with the ability to convey complex scientific and strategic concepts clearly to both technical and non-technical audiences\r\nExperience working effectively in a matrixed environment and leading cross-functional teams.\r\nBenefits: Medical\r\nDental\r\nVision\r\n401(k)\r\nFSA/HSA\r\nLife Insurance\r\nPaid Time Off\r\nWellness","datePosted":"2026-05-14T03:49:26.549Z","dateModified":"2026-05-14T03:49:26.549Z","hiringOrganization":{"@type":"Organization","name":"Remote Rocketship","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"8b302d959cf3efaa657d8d3f"},"url":"https://jobsearcher.com/jobs/8b302d959cf3efaa657d8d3f"}}