Clinical Scientist (Manager), Translational Science and Medicine (TSM)-Immunology

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: Clinical Development & Research – Non-MD Job Category: Scientific/Technology All Job Posting Locations: La Jolla, 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. The Clinical Science group within Translational Science & Medicine (TSM) is seeking a Manager, Clinical Scientist based in Spring House, PA, Cambridge, MA or La Jolla, CA to support the design, development and execution of early clinical development and experimental medicine studies within the Immunology Therapeutic Area. TSM Clinical Scientists are key contributors to the development of transformative therapies for patients with immune-mediated diseases. They partner closely with disease area experts and colleagues across Biomarkers, Digital Health, Clinical Pharmacology, Global Development Operations, and other functions to generate translational and clinical insights that inform development strategy, guide portfolio decisions, and accelerate the advancement of innovative therapies from Discovery to late-stage clinical development. The primary responsibility of this role is to serve as a Study Responsible Scientist (SRS), working closely with the Study Responsible Physician, Clinical Leads, and cross-functional study team members to support the planning, conduct, analysis, and reporting of Phase 0, Phase 1, and Phase 2a clinical studies. Key responsibilities include contributing to the development of clinical trial protocols, clinical study reports, and other study-related deliverables, as well as supporting study execution through activities such as medical data review and data cleaning. The role requires a solid understanding of clinical development, clinical trial documentation, regulatory requirements, and operational processes. We are seeking a highly motivated scientist with a BS, MS, PharmD, PhD, or RN degree, relevant pharmaceutical or biotechnology industry experience, and preferably a background in Immunology, Gastroenterology or a related scientific discipline. The successful candidate will thrive in a collaborative, matrixed environment and possess a passion for advancing transformational therapies from early development through proof of concept and beyond. Essential Job Duties and Responsibilities Support the execution of clinical trial protocols of the clinical development plan, ensuring compliance with scientific, organizational, and regulatory standards. Support end-to-end delivery of clinical trial protocols, including study design, initiation, medical data monitoring, data dissemination, and closeout activities. Co-manage and coordinate trial activities with internal, cross-functional and external (e.g., vendors, clinical sites) partners to ensure timely execution of clinical trials and to ensure the quality and integrity of data is critical to the evaluation of study endpoints. Support providing training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes. Support the review, interpretation, and reporting of clinical trial data, assisting with ensuring accuracy and integrity for health authority submissions. Contribute to the preparation of documents for reporting clinical trial data (e.g. clinical study reports, patient narratives, investigator brochures, and periodic safety updates). Contribute to the medical data monitoring activities in partnership with the Study Responsible Physician, including the evaluation, documentation, and reporting of ongoing clinical trial data per defined medical data review plan. Contribute to process improvements and implementation of best practices in clinical trial execution. Collaborate with cross-functional partners to support clinical strategies with overall product development goals. Contributes to the preparation and presentation of the results of clinical research in internal department/ management meetings. May also support the preparation of materials for external expert engagements. Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO). Qualifications A minimum of a bachelor’s degree with a scientific background in Immunology or a related field is required. An advanced degree (e.g., MS, PharmD, PhD) is preferred. A scientific background in Gastroenterology is preferred. Requires at least 3-5 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO, or equivalent. Experience with Ph 0, 1 and 2a studies in immunology indications is preferred. Understanding clinical development processes, including trial design, protocol development, data analysis, regulatory guidelines, Good Clinical Practice (ICH GCP), and study execution. Proven the ability to interpret scientific literature and apply findings strategically within clinical projects. Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint, and familiarity with generative artificial intelligence and clinical trial management software is advantageous. Excellent written and verbal communication skills; ability to effectively present information to the stakeholders. Strong interpersonal skills with a collaborative approach to working within cross-functional and global matrix teams. Strong organizational skills with the ability to multi-task and prioritize assignments. Proven analytical and problem-solving capabilities, with a detail-oriented mindset. Ability to proactively identify study level issues/discussions that require escalation. Ability to handle study projects to overcome delays and obstacles to meet deadlines. Strong project and time management skills. Willingness to travel domestically and internationally, approximately 10%, as required by project needs. A commitment to maintaining high ethical standards and fostering a culture of inclusivity in the workplace. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan