Senior Manager, Global Diagnostics Lead- Oncology Precision Medicine Diagnostics

Johnson & Johnson • Titusville, NJ

1d • Hybrid

About The Position

Johnson & Johnson’s Oncology Precision Medicine Diagnostics team is seeking a Senior Manager, Global Diagnostic Lead to contribute to diagnostic strategies supporting oncology drug development. Working with a more senior Diagnostic Lead and cross-functional stakeholders, this individual will independently lead defined diagnostic programs or major workstreams from biomarker hypothesis through clinical testing and assay validation, and, where applicable, companion diagnostic development. This developmental leadership role offers increasing accountability for diagnostic strategy and execution, with senior oversight for consequential regulatory, partner-selection, investment, and portfolio decisions.

The role involves coordinating diagnostic strategy and delivery with internal functions and external partners; overseeing assay development and clinical sample testing; supporting regulatory and quality activities; and providing scientific and technical recommendations. The position may be based in Spring House, PA; Titusville, PA; Raritan, NJ; Cambridge, MA; or San Diego, CA.

Requirements

• PhD in a relevant scientific discipline and at least 3 years of relevant industry experience, or a Master’s degree in a relevant scientific discipline 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 how intended use relates to 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 with contract laboratories, diagnostic companies, technology providers, or other external partners.
• Strong project-management skills, including management of 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 matrixed, collaborative, global environment.

Nice To Haves

• One to two years of experience in a diagnostic leadership or 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.
• Experience in hematologic oncology.
• Experience spanning more than one stage of clinical oncology development.
• Experience supporting clinical-trial assays 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.
• Working familiarity with United States and global diagnostic regulatory requirements.
• Experience working with clinical samples and related sample-management, data-quality, or testing-operational considerations.

Responsibilities

• Contribute to end-to-end diagnostic strategies aligned with clinical development plans, regulatory strategies, and anticipated registration timelines.
• Independently lead assigned diagnostic programs or major workstreams with strategic 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; communicate progress, decisions, risks, and recommendations, and escalate significant matters to senior leadership.
• Provide diagnostic input to clinical protocols, biomarker plans, sample strategies, and integrated development plans.
• Collaborate with Translational Research, Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Commercial, and other relevant functions.
• Lead cross-functional diagnostic workstreams, facilitate discussions, document decisions and actions, and drive follow-through without direct authority.
• Partner with colleagues to design studies assessing assay performance, 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; evaluate assay performance and contribute to appropriate validation plans and requirements.
• Oversee assigned clinical sample-testing activities and monitor testing quality, data delivery, timelines, and operational performance.
• Work with clinical and operational teams to resolve sample availability, sample quality, testing capacity, data-transfer, and related execution issues.
• Coordinate 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.
• Support senior Diagnostic Leads in strategic partner selection, negotiations, contracting discussions, and governance interactions.
• Apply working knowledge of CLIA, CAP, FDA, and relevant global diagnostic requirements; collaborate on regulatory documentation and contribute diagnostic content to submissions, briefing documents, health-authority responses, and other deliverables.
• Participate in health-authority preparation and interactions as appropriate, maintain quality-system documentation and decision records, and keep current on evolving diagnostic regulatory expectations.
• Maintain knowledge of oncology biomarkers, diagnostic technologies, assay platforms, regulations, and industry trends; evaluate emerging technologies and recommend applications to assigned programs.
• Present diagnostic plans, results, risks, and recommendations to program teams and governance forums, and share technical knowledge and best practices across the organization.

Benefits

• May be eligible for an annual performance bonus.
• Employees and/or eligible dependents may be eligible to participate in company-sponsored employee benefit programs.
• Employees may be eligible to participate in applicable retirement and savings plans.
• Employees may be eligible for applicable time-off benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior