Raritan, New Jersey, United States of America, United States of America
Hybrid
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Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Clinical Development & Research – Non-MDJob Category:
Scientific/TechnologyAll Job Posting Locations:
Cambridge, Massachusetts, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of AmericaJob Description:
Johnson & Johnson (J&J) is seeking an Associate Director, Clinical Scientist (Biomarker Integration, Neuroscience) to be located in Titusville, NJ; Raritan, NJ; Spring House, PA; San Diego, CA; or Cambridge, MA.
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 Neuroscience team tackles the world’s toughest brain health challenges including multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, myasthenia gravis, epilepsy, major depressive disorder, bipolar disorder, schizophrenia, and autism. This patient-focused team helps address some of the most complex diseases of our time.
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
The Associate Director, Biomarker Integration, Neuroscience is responsible for leading the implementation of end-to-end biomarker strategies for assigned Neuroscience clinical development programs. This role partners cross-functionally to ensure biomarker integration aligned with clinical program objectives, regulatory requirements, and Precision Measures Plans. Close collaboration with Precision Measures, Global Development, Biospecimen Management, Clinical Scientists, Data Sciences, Statistics, Clinical Operations, Regulatory, Commercial, and external partners is required to ensure coordinated execution.
This role is a core member of the clinical team and may also participate in translational and/or diagnostic expert teams as required to support clinical program strategy and execution.
Duties and responsibilities include, but are not limited to the following:
Drives the incorporation of biomarker strategies into study design, execution, and reporting. This includes contributing to key clinical and operational documents, overseeing assay selection and validation, and ensuring high-quality biomarker data generation, analysis, and interpretation to support decision-making.
Responsible for analysis, interpretation and reporting of fluid & tissue biomarker data in assigned NS clinical development programs and for implementing the sample retention strategy.
Responsible for the translation and implementation of non-medical scientific concepts into the study design and/or program across planning, execution, and reporting including integration of biomarkers, digital technologies, data science initiatives, and select vendor's clinical strategies.
Responsible for scientific oversight of external vendors and contract laboratories, ensuring appropriate assay methodologies, data quality, and timely delivery of results.
Manages biospecimen strategy implementation, including sample retention, inventory management, and end-to-end tracking for all human samples from clinical development programs, including budgetary and contractual oversight and governance, to maximize the long-term value of clinical samples across the portfolio.
Serves as a key interface between Precision Measures and Clinical Development for assigned programs, ensuring effective knowledge transfer of validated biomarker assays and enabling consistent implementation across programs.
Develops and delivers training on topics related to biomarker integration to clinical teams and cross-functional stakeholders.
Education and Experience:
PhD Degree is required with a minimum of 6 years industry experience
A minimum of 8 years of drug discovery & development experience is strongly preferred
Experience with biomarker development and implementation and clinical development is required; experience with IVD or diagnostics development preferred
Neuroscience experience is strongly preferred
Exceptional analytical and critical thinking skills, with the ability to translate complex data and information into actionable insights for independent decision making
Excellent interpersonal skills, with the ability to build strong relationships and influence without reporting authority
Exceptional communication and presentation skills, with the ability to clearly articulate complex ideas to cross functional teams and stakeholders.
Proven experience and expertise in managing in a matrix organizational structure
Required Technical Knowledge and Skills
Fluent in written and spoken English
Working knowledge of the use of Microsoft suite of software products including Excel and Word
Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Belgium- Requisition Number: R-082556
United States- Requisition Number: R-080001
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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$137,000.00 - $235,750.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Want to know if this job is worth applying to?