Senior Manager, Global Diagnostics Lead- Oncology Precision Medicine Diagnostics

Job description

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 MedTech, 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. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Translational Discovery & Development Biomarkers Job Category: Scientific/Technology All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: About Innovative Medicine 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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine About Oncology 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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine 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. We are seeking a highly motivated individual to join the Oncology Precision Medicine Diagnostics team. The Senior Manager, Global Diagnostic Lead will contribute to the development and execution of diagnostic strategies supporting oncology drug development programs. Working in close partnership with a more senior Diagnostic Lead and cross-functional stakeholders, this individual will independently lead one or more 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 an individual who has established experience in oncology biomarkers, clinical assay development, in vitro diagnostics, clinical laboratory testing, or companion diagnostics and has begun to demonstrate diagnostic leadership. The role will provide increasing accountability for diagnostic strategy and execution while maintaining senior oversight for consequential regulatory, partner-selection, investment, and portfolio-level decisions. Responsibilities Include: Diagnostic Strategy and Program Leadership 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 workstreams 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 escalate 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. Cross-Functional Leadership 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 workstreams 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. Assay and Clinical Testing Oversight 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 capacity, data-transfer, and related execution issues. External Partner Management Lead and be accountable for the end-to-end execution of assigned diagnostic projects, coordinating contract laboratories, diagnostic partners, and cross-functional stakeholders to deliver against agreed objectives, timelines, and milestones. Contribute to technical evaluations, requests for information, feasibility assessments, scopes of work, budgets, and partner-selection recommendations. Monitor partner performance and escalate issues that could affect data quality, clinical timelines, regulatory deliverables, or pharmaceutical registration. Support senior Diagnostic Leads in strategic partner selection, negotiations, contracting discussions, and governance interactions. Regulatory and Quality Support 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 to support preparation of regulatory documentation. Contribute diagnostic content to briefing documents, investigational submissions, responses to health-authority questions, 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. Scientific and Technical Leadership Maintain current knowledge of oncology biomarkers, diagnostic tech