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Senior Manager, Global Diagnostics Lead – Oncology Precision Medicine Diagnostics
Johnson & Johnson. Contribute to end-to-end diagnostic strategies aligned with clinical development, regulatory strategy, and pharmaceutical registration timelines .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in diagnostic program leadership, biomarker development, and assay validation, with a strong focus on regulatory compliance and cross-functional collaboration. Proven ability to manage complex projects and coordinate with external partners in the clinical and diagnostic landscape.
Highest-signal resume keywords
PhD In Molecular BiologyOncology Biomarker DevelopmentAssay Development And ValidationProject ManagementCross-Functional Team Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Diagnostic Development PlansClinical ProtocolsAnalytical Performance StudiesSample StrategiesRegulatory DocumentationFeasibility AssessmentsQuality-System RecordsMolecular Response EvaluationClinical Utility StudiesDisease Monitoring
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationInfluencing Without AuthorityCollaborationLeadership
Tools & Technologies
CLIACAPFDAContract LaboratoriesDiagnostic Partners
Industry Keywords
PharmaceuticalBiotechnologyDiagnosticsMedical-DeviceClinical-LaboratoryTranslational Medicine
About the role
Key responsibilities & impact- Contribute to end-to-end diagnostic strategies aligned with clinical development, regulatory strategy, and pharmaceutical registration timelines
- Independently lead defined diagnostic programs or major workstreams
- Translate biomarker objectives into diagnostic development plans, timelines, risks, decision points, and deliverables
- Serve as day-to-day diagnostic point of contact for assigned program teams
- Provide diagnostic input into clinical protocols, biomarker plans, sample strategies, and integrated development plans
- Lead cross-functional diagnostic workstreams and drive alignment and delivery
- Design studies evaluating analytical performance, clinical performance, clinical utility, patient selection, disease monitoring, measurable residual disease, or molecular response
- Manage assay development, transfer, optimization, verification, and validation activities
- Oversee clinical sample-testing activities and monitor testing quality, data delivery, timelines, and operational performance
- Coordinate contract laboratories, diagnostic partners, and cross-functional stakeholders
- Support technical evaluations, feasibility assessments, scopes of work, budgets, and partner-selection recommendations
- Apply CLIA, CAP, FDA, and global diagnostic requirements to assigned activities
- Support regulatory documentation, submissions, health-authority responses, and quality-system records
- Evaluate emerging technologies and present diagnostic plans, results, risks, and recommendations
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
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