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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 https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub** **Function:

Translational Discovery & Development Biomarkers

Job Category:

Scientific/Technology

All Job Posting Locations:

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 Senior Scientist, Clinical Biomarkers Operations, Translational Sciences (TS), Immunology Translational Sciences and Medicine (TSM) to be located in Spring House, PA.

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 human based data and tissues 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 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. The TS organization accomplishes these goals by integrating expertise in biomarker development, disease biology research and in the application of immunology and data science technologies to support drug discovery and development.

We are seeking a highly motivated individual to join the TS Clinical Biomarker Operations team. As a key contributor to the clinical biomarker and diagnostic strategy, this individual will be accountable for the implementation and execution of clinical sample collection, testing and data delivery activities for both early and late phase clinical programs in the Immunology therapeutic area. The successful candidate will have experience bridging both science and operations through cross-functional partnerships, strategic project planning and facilitating key biomarker delivery discussions.

Responsibilities are as follows:

+ Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical programs in early and late-stage immunology clinical programs

+ Creates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and quality metrics during study startup, conduct and closeout

+ Work effectively with procurement and scientific leads to execute contracts and statements of work to meet program deliverables

+ Contributes to central lab setup and management throughout the course of a study

+ Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are processed, tested and data is reported to meet development timelines and specifications

+ Works closely with data management to establish data collection and transfer processes with testing vendors and local labs

+ Contributes to the preparation of clinical documents such as clinical protocol, clinical study reports, lab manuals, informed consent forms, sample management plan, early development plans and site training materials

+ Works with scientific stakeholders to identify innovative bio sample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards

+ Develops presentations and shares biomarker plan, project timelines, sample tracking/testing metrics at regular team meetings

+ May work with scientific stakeholders to evaluate and implement new assays and relevant technologies as required by the program

+ Manages relationships with internal and external partners to ensure on-time and quality deliverables

+ Participates in cross-functions study team meetings across clinical, translational research and diagnostics.

Qualifications:

+ Bachelor’s degree in a scientific discipline with 3–5 years of relevant experience, or MS/Ph.D with at least 1 year of experience in in clinical development, and/or biomarker or diagnostics development and/or Pharmaceutical/biotech R&D

+ Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP is required

+ Project management experience is preferred

+ Knowledge of drug development and/or biomarker/diagnostic development is preferred

+ Excellent written and verbal communication skills

+ Ability to effectively and collaboratively work on global cross-functional teams

+ Strong organizational skills and attention to detail; ability to manage multiple tasks simultaneously and troubleshoot effectively

+ Background in inflammation or immunology research is strongly preferred

+ Proactive mindset with a strong desire to learn and grow professionally

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.

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Required Skills:

GLP Regulations, ICH GCP Guidelines, Immunology

Preferred Skills:

Biomarkers, Clinical Trial Designs, Coaching, Communication, Critical Thinking, Drug Discovery Development, Human-Centered Design, Interdisciplinary Work, Medical Compliance, Medical Technology, Quality Standards, Research Documents, Safety-Oriented, Scientific Research, Technologically Savvy, Translational Medicine