Associate Director, Clinical Biomarker Operations-Translational Sciences-Immunology

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: Cambridge, Massachusetts, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, 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 Immunology 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 Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. 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 Associate Director, Clinical Biomarker Operations, Translational Science-Immunology, to be in Spring House, PA, La Jolla, CA or Cambridge, MA. Immunology Translational Sciences and Medicine (TSM) is an integrated group of scientists composed of a clinical Translational Medicine (TM) team which conducts early clinical development and experimental medicine studies, and a Translational Sciences (TS) team which uses clinical data and scientific insights to support the end-to-end portfolio. Together, the TSM group will provide the key learnings/insights on the next wave of novel therapies for these patients. Organizationally, TSM serves as a pivotal bridge between Discovery Research and the later phase Clinical Development group. TSM provides the necessary scientific and clinical expertise to advance an industry-leading pipeline of novel mechanism small molecules and biologic agents to address unmet need in immune-mediated diseases. TS has a broad remit stretching from support of discovery with human data to support target selection, through development of novel decision-making biomarkers for early phase clinical trials, target-centric indication sequencing and prioritization, and biomarker support of regulatory filings. It has expertise in biomarker development, disease biology research and in the application of immunology and data science technologies to support drug discovery and development. The Associate Director, Clinical Biomarker Operations provides operational leadership for the execution of clinical biomarker plans across late-stage development programs. This role is accountable for translating biomarker strategy into fit-for-purpose operational plans and ensuring the timely, compliant, and high-quality delivery of biospecimen collection, laboratory testing, and biomarker data. The Associate Director manages external laboratory partners, influences cross-functional decisions, and helps advance scalable processes and standards for clinical biomarker operations. Responsibilities are as follows: Lead the operational planning and execution of clinical biomarker strategies across multiple complex studies or development programs. Develop and maintain integrated biomarker operational plans, timelines, budget tracking, risk assessments, quality metrics, and resource forecasts from study start-up through closeout. Ensure end-to-end oversight of biospecimen collection, processing, shipment, storage, reconciliation, testing, and final disposition in accordance with protocols, informed consent, laboratory manuals, and applicable requirements. Provide biomarker operations input to clinical protocols, informed consent forms, laboratory manuals, sample management plans, investigator materials, data transfer specifications, and other study documents. Lead central and specialty laboratory strategy, including vendor evaluation, selection, qualification, contracting, onboarding, performance oversight, issue resolution, and closeout. Partner with scientific leads to operationalize fit-for-purpose biomarker assays and ensure assay readiness, testing capacity, sample availability, and data delivery align with program milestones. Collaborate with Clinical Operations, Translational Science, Data Management, Procurement, Quality, Regulatory, Clinical Development, and regional teams to integrate biomarker deliverables into clinical study execution. Establish and oversee sample- and data-tracking processes; monitor key performance indicators, investigate discrepancies, and drive timely corrective and preventive actions. Proactively identify operational, quality, regulatory, budget, and timeline risks; develop mitigation plans and escalate issues with clear options and recommendations. Ensure activities comply with company procedures, ICH GCP, applicable GLP principles, privacy requirements, ethical standards, and local and global regulatory expectations. Support inspection and audit readiness by maintaining complete, accurate, and traceable biomarker operations documentation and by coordinating responses with internal and external partners. Drive process improvement and operational excellence initiatives, including development of standards, templates, guidance, training, and technology-enabled workflows. Represent Clinical Biomarker Operations on cross-functional study and program teams and communicate status, ris