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Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Translational Discovery & Development Biomarkers Job Category: People Leader
All Job Posting Locations: 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
Johnson and Johnson is recruiting for a Director, Clinical Biomarker Operations to be located in Spring House, PA, Cambridge, MA, or La Jolla, CA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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.
This position resides within the Immunology Translational Sciences group and requires a highly motivated, skilled and proactive candidate to drive the translational research for innovative therapies across immune-mediated diseases. The Director, Clinical Biomarker Operations will lead the Immunology biomarker operations function within Translational Science.
Responsibilities:
• Define and drive the biomarker operations strategy for Immunology Translational Science, including definition of roles, responsibilities, and ways of working • Establish, implement, and maintain standardized biomarker operations processes and SOPs to ensure consistent execution across programs • Provide operational leadership across early and late-stage Immunology clinical programs, overseeing biomarker plans, timelines, budgets, risks, and quality metrics • Provide expert biomarker and diagnostic development input into required clinical documents such as protocols, ICF, IB, and lab manuals • Ensure end-to-end execution of biospecimen collection, testing, and data delivery to meet clinical development needs • Ensure compliance with global regulatory requirements, ICH GCP, GLP, and quality standards for biomarker and diagnostic deliverables • Shape and lead biomarker vendor strategy, setup, and lifecycle management for Immunology studies, oversee vendor selection and performance management in partnership with Procurement and scientific stakeholders • Drive continuous improvement in efficiency, quality, and scalability of clinical biomarker operations • Identify and foster critical collaborations with strategic partners, vendors, and external collaborators • Evaluate, select, and develop strategic partnerships to position the organization for future business needs • Develop and maintain strong relationships with internal and external stakeholders • Communicate progress, challenges, and changes that may impact timelines to leadership • Serve as the single point of accountability for biomarker operational execution within Immunology Translational Science • Lead, mentor, and develop the Immunology biomarker operations team, setting clear expectations and fostering a high-performing culture • Establish internal working groups to develop best practices and operational solutions
Qualifications:
Advanced degree in Life Sciences, Biomedical Sciences, Medicine, or related discipline 8+ years of experience in clinical biomarker operations within pharmaceutical or biotechnology R&D, with 3+ years in a leadership role Demonstrated people leadership skills in a matrixed environment and cross-functional influencing experience Extensive hands-on experience with compliance/oversight of operationalizing clinical biomarker assays, contracting service laboratories, and biosample tracking systems Proven ability to build and scale SOP-driven operational models and to effectively prioritize, organize, and lead cross-functional projects Strong knowledge and understanding of clinical research, ICH GCP, GLP; Familiarity with global health authority interactions Proven track record of evaluating, selecting, and developing strategic partnerships with vendors and external collaborators Experience supporting Immunology clinical programs strongly preferred Direct people management experience strongly preferred
Required Skills:
• Biomarkers • Business Savvy • Clinical Trials Operations • Developing Others • Drug Discovery Development • Inclusive Leadership • Industry Analysis • Interdisciplinary Work • Leadership • Medical Compliance • Medical Technology • Organizational Project Management • Product Development • Quality Standards • Scientific Research • Stakeholder Management • Technologically Savvy • Translational Medicine
The anticipated base pay range for this position is: $160,000 - $276,000
Additional Description for Pay Transparency:
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Preferred Skills:
• Biomarkers • Business Savvy • Clinical Trials Operations • Developing Others • Drug Discovery Development • Inclusive Leadership • Industry Analysis • Interdisciplinary Work • Leadership • Medical Compliance • Medical Technology • Organizational Project Management • Product Development • Quality Standards • Scientific Research • Stakeholder Management • Technologically Savvy • Translational Medicine
The anticipated base pay range for this position is: $164,000.00 - $282,900.00
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Our Family of Companies comprises:
The world’s sixth-largest consumer health company.
The world’s most comprehensive medical devices business.
The world’s sixth-largest biologics company.
And the world’s fifth-largest pharmaceuticals company.
We have more than 265 operating companies in more than 60 countries employing approximately 126,500 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.