Senior Manager, Global Diagnostics Lead- Oncology Precision Medicine Diagnostics

Johnson & Johnson Innovative Medicine • Hopewell Township, NJ

2d • $137,000 - $235,750 • Hybrid

About The Position

Johnson & Johnson is seeking a Senior Manager, Global Diagnostic Lead to join its Oncology Precision Medicine Diagnostics team. The role contributes to the development and execution of diagnostic strategies supporting oncology drug development. In partnership with a more senior Diagnostic Lead and cross-functional stakeholders, the role independently leads defined diagnostic programs or major workstreams from biomarker hypothesis through clinical testing, assay validation, and, where applicable, companion diagnostic development.

This is a developmental Global Diagnostic Lead opportunity for someone with established experience in oncology biomarkers, clinical assay development, in vitro diagnostics, clinical laboratory testing, or companion diagnostics who has begun to demonstrate diagnostic leadership. The position provides increasing accountability for diagnostic strategy and execution while senior leaders retain oversight of consequential regulatory, partner-selection, investment, and portfolio-level decisions.

The role works across Translational Research, Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Commercial, contract laboratories, diagnostic partners, and other stakeholders. It supports assay and clinical-testing activities, external partner execution, regulatory and quality documentation, and scientific and technical evaluation for assigned oncology development programs. The anticipated base pay range is $137,000–$235,750. The position may be eligible for an annual performance bonus and participation in company-sponsored benefits, retirement and savings plans, and applicable time-off benefits.

Requirements

• PhD in molecular biology, biochemistry, genetics, immunology, pathology, biomedical sciences, or another relevant scientific discipline and at least 3 years of relevant industry experience; alternatively, a relevant Master's degree and at least 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, including the relationship between intended use and analytical performance requirements.
• 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, including managing timelines, dependencies, risks, decisions, and deliverables.
• Strong written and verbal communication skills and ability to communicate scientific and technical information to multidisciplinary stakeholders.
• Demonstrated ability to lead cross-functional teams and influence without direct authority in a highly matrixed, collaborative, global environment.

Nice To Haves

• One to two years of experience in diagnostic leadership or a comparable workstream-lead role, such as Diagnostic Lead, deputy or supporting Diagnostic Lead, diagnostic subteam lead, biomarker lead, assay-development or validation lead, clinical-testing lead, or laboratory or diagnostic-partner lead.
• Experience supporting oncology biomarker or diagnostic development; hematologic oncology experience is a plus.
• Experience spanning more than one stage of clinical oncology development.
• Experience supporting clinical-trial assays used for patient selection, treatment assignment, efficacy endpoints, disease monitoring, measurable residual disease, or molecular response assessment.
• Exposure to companion diagnostic development models, including kit-based and single-site laboratory approaches.
• Experience reviewing or contributing to assay-validation plans, clinical study documents, regulatory submissions, or health-authority responses; prior ownership of a regulatory submission is not required.
• Working familiarity with United States and global diagnostic regulatory requirements.
• Experience working with clinical samples and associated sample-management, data-quality, or testing-operational considerations.

Responsibilities

• Contribute to end-to-end diagnostic strategies aligned with clinical development plans, regulatory strategy, and anticipated pharmaceutical registration timelines.
• Independently lead assigned diagnostic programs or major workstreams with guidance and oversight from senior diagnostic leadership.
• Translate clinical and translational biomarker objectives into diagnostic development plans, timelines, risks, decision points, and deliverables.
• Serve as the day-to-day diagnostic contact for assigned program teams and communicate progress, decisions, risks, and recommendations.
• Make recommendations within assigned scope and escalate significant strategic, regulatory, quality, budget, partner, or timeline decisions.
• Provide diagnostic input into clinical protocols, biomarker plans, sample strategies, and integrated development plans.
• Collaborate with cross-functional teams to execute diagnostic strategies and lead workstreams, influence without direct authority, facilitate discussions, document decisions, and drive follow-through.
• Partner on studies evaluating analytical and clinical performance, clinical utility, patient selection, disease monitoring, measurable residual disease, or molecular response, as applicable.
• Support selection of fit-for-purpose assay technologies, contract laboratories, and diagnostic development partners.
• Manage assay development, transfer, optimization, verification, and validation activities for assigned programs.
• Work with subject matter experts to evaluate assay performance and ensure validation plans are appropriate for intended use.
• Develop or contribute to analytical validation requirements for exploratory, clinical-trial, investigational, or companion diagnostic assays.
• Oversee assigned clinical sample-testing activities and monitor testing quality, data delivery, timelines, and operational performance.
• Work with clinical and operational teams to address sample availability, sample quality, testing capacity, data-transfer, and related execution issues.
• Lead end-to-end execution of assigned diagnostic projects with contract laboratories, diagnostic partners, and cross-functional stakeholders.
• Contribute to technical evaluations, requests for information, feasibility assessments, scopes of work, budgets, and partner-selection recommendations.
• Monitor partner performance and escalate issues that may affect data quality, clinical timelines, regulatory deliverables, or pharmaceutical registration.
• Support senior Diagnostic Leads with strategic partner selection, negotiations, contracting discussions, and governance interactions.
• Apply working knowledge of CLIA, CAP, FDA, and relevant global diagnostic requirements to assigned clinical assay and diagnostic activities.
• Collaborate with Regulatory Affairs and diagnostic subject matter experts on regulatory documentation and contribute diagnostic content to briefing documents, investigational submissions, health-authority responses, and other regulatory deliverables.
• Participate in health-authority preparation and interactions as appropriate, with support from senior diagnostic and regulatory colleagues.
• Maintain documentation and decision records consistent with applicable quality systems and program governance expectations.
• Maintain awareness of evolving United States and global regulatory expectations for oncology biomarkers, clinical assays, and companion diagnostics.
• Keep current with oncology biomarkers, diagnostic technologies, assay platforms, regulatory developments, and industry trends.
• Evaluate emerging technologies and recommend potential applications to assigned development programs.
• Contribute to diagnostic methodology selection based on intended use, analytical performance, clinical requirements, sample availability, development timelines, and regulatory considerations.
• Present diagnostic plans, results, risks, and recommendations to cross-functional program teams and governance forums.
• Contribute to a collaborative team environment and share technical knowledge and best practices across the Oncology Precision Medicine Diagnostics organization.

Benefits

• Potential eligibility for an annual performance bonus under the applicable plan.
• Potential eligibility to participate in company-sponsored employee benefit programs.
• Potential eligibility to participate in applicable retirement and savings plans.
• Potential eligibility for applicable time-off benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree