Senior Manager, Global Diagnostics Lead – Oncology Precision Medicine Diagnostics

Johnson & Johnson

. Contribute to end-to-end diagnostic strategies aligned with clinical development plans, regulatory strategies, and pharmaceutical registration timelines .

Posted 10/14/2026full-timeUnited StatesSenior💰 $137,000 - $235,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in diagnostic program leadership, biomarker development, and assay validation within oncology. Proficient in cross-functional collaboration, regulatory compliance, and project management to drive successful diagnostic strategies and clinical outcomes.

Highest-signal resume keywords

PhD In Molecular BiologyOncology Biomarker DevelopmentAssay Development And ValidationProject ManagementCross-Functional Team Leadership

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Hard Skills

Biomarker Objectives TranslationClinical Protocol DevelopmentAnalytical Performance EvaluationClinical Utility AssessmentSample ManagementRegulatory DocumentationFeasibility AssessmentsData Quality MonitoringAssay Technology SelectionClinical Trial Assays

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationInfluencing Without AuthorityCollaborationProblem-Solving

Industry Keywords

CLIACAPFDATranslational MedicineIn Vitro Diagnostic DevelopmentCompanion Diagnostic DevelopmentClinical Laboratory TestingRegulatory AffairsBiostatisticsClinical Operations

About the role

Key responsibilities & impact

Contribute to end-to-end diagnostic strategies aligned with clinical development plans, regulatory strategies, and pharmaceutical registration timelines
Independently lead defined diagnostic programs or major workstreams with senior diagnostic oversight
Translate biomarker objectives into diagnostic development plans, timelines, risks, decision points, and deliverables
Serve as the day-to-day diagnostic point of contact for assigned program teams
Communicate progress, decisions, risks, and recommendations to stakeholders
Provide diagnostic input into clinical protocols, biomarker plans, sample strategies, and integrated development plans
Collaborate with Translational Research, Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Commercial, and other functions
Lead cross-functional diagnostic workstreams and drive alignment, accountability, and delivery
Design studies evaluating analytical performance, clinical performance, clinical utility, patient selection, disease monitoring, measurable residual disease, or molecular response
Facilitate diagnostic discussions, document decisions and actions, and drive follow-through
Support selection of assay technologies, contract laboratories, and diagnostic development partners
Manage assay development, transfer, optimization, verification, and validation activities
Oversee clinical sample-testing activities and monitor quality, data delivery, timelines, and operational performance
Resolve sample availability, sample quality, testing capacity, data-transfer, and execution issues
Coordinate contract laboratories, diagnostic partners, and cross-functional stakeholders to deliver project objectives and milestones
Contribute to technical evaluations, feasibility assessments, scopes of work, budgets, and partner-selection recommendations
Monitor partner performance and escalate issues affecting data quality, clinical timelines, regulatory deliverables, or registration
Support partner selection, negotiations, contracting discussions, and governance interactions
Apply knowledge of CLIA, CAP, FDA, and global diagnostic requirements
Support regulatory documentation, submissions, health-authority responses, and interactions
Maintain quality-system documentation and decision records
Evaluate emerging technologies and recommend applications to development programs
Present diagnostic plans, results, risks, and recommendations to program teams and governance forums
Share technical knowledge and best practices across the Oncology Precision Medicine Diagnostics organization

Requirements

What you’ll need

PhD in molecular biology, biochemistry, genetics, immunology, pathology, biomedical sciences, or another relevant scientific discipline with a minimum of 3 years of relevant industry experience; or a Master's degree in a relevant scientific discipline with a minimum of 6 years of relevant industry experience
Relevant pharmaceutical, biotechnology, diagnostics, medical-device, or clinical-laboratory experience in oncology biomarker development, clinical assay development or validation, in vitro diagnostic development, companion diagnostic development, clinical laboratory testing, or translational medicine
Working knowledge of assay development and validation principles
Experience contributing to cross-functional drug-development, biomarker, clinical-testing, or diagnostic programs
Demonstrated experience leading at least one diagnostic, biomarker, assay-development, assay-validation, clinical-testing, or external-partner workstream
Experience supporting biomarkers or diagnostics in early or late clinical development
Experience coordinating activities with contract laboratories, diagnostic companies, technology providers, or other external partners
Strong project-management skills
Strong written and verbal communication skills
Demonstrated ability to lead cross-functional teams and influence without direct authority in a highly matrixed, collaborative, and global environment
One to two years of experience serving in a diagnostic leadership or comparable workstream-lead role preferred
Experience supporting oncology biomarker or diagnostic development preferred; hematologic oncology experience is a plus but not required
Experience spanning more than one stage of clinical oncology development preferred
Experience supporting clinical trial assays for patient selection, treatment assignment, efficacy endpoints, disease monitoring, measurable residual disease, or molecular response assessment preferred
Exposure to companion diagnostic development models preferred
Experience reviewing or contributing to assay-validation plans, clinical study documents, regulatory submissions, or health-authority responses preferred
Working familiarity with United States and global diagnostic regulatory requirements preferred
Experience working with clinical samples and associated sample-management, data-quality, or testing-operational considerations preferred

Benefits

Comp & perks

Annual performance bonus eligibility
Company-sponsored employee benefit programs for employees and/or eligible dependents
Retirement and savings plans
Applicable time-off benefits