Senior Manager, Global Diagnostics Lead- Oncology Precision Medicine Diagnostics

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Discovery & Pre-Clinical/Clinical Development

Translational Discovery & Development Biomarkers

Scientific/Technology

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

We are searching for the best talent for a Senior Manager, Global Diagnostic Lead, Oncology Precision Medicine Diagnostics to be located in Springhouse, PA, Titusville, PA, Raritan, NJ, Cambridge, MA, San Diego, CA.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to find treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

• Contribute to the development of end-to-end diagnostic strategies aligned with the clinical development plan, regulatory strategy, and anticipated pharmaceutical registration timelines.
• Independently lead one or more defined diagnostic programs or major work streams with strategic guidance and oversight from an Associate Director, Director, or Scientific Director.
• Translate clinical and translational biomarker objectives into actionable diagnostic development plans, timelines, risks, decision points, and deliverables.
• Serve as the day-to-day diagnostic point of contact for assigned program teams and communicate progress, decisions, risks, and recommendations to appropriate stakeholders.
• Make recommendations within the assigned scope and promptly escape significant strategic, regulatory, quality, budget, partner, or timeline decisions to senior diagnostic leadership.
• 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 relevant functions to execute the diagnostic strategy.
• Lead cross-functional diagnostic work streams and influence without direct authority to drive alignment, accountability, and timely delivery.
• Partner with Translational Research and Clinical Development colleagues to design studies evaluating analytical performance, clinical performance, clinical utility, patient selection, disease monitoring, measurable residual disease, or molecular response, as applicable.
• Facilitate cross-functional diagnostic discussions, document decisions and actions, and drive follow-through on agreed deliverables.

• Support identification and 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 internal subject matter experts to evaluate assay performance and confirm that validation plans are appropriate for the assay 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.
• Partner with clinical and operational teams to identify and resolve sample availability, sample quality, testing…