Associate Director, Clinical Scientist (biomarker Integration, Neuroscience)

Johnson & Johnson Johnson & Johnson · Pharma · Raritan, NJ +7

Johnson & Johnson is seeking an Associate Director, Clinical Scientist specializing in Biomarker Integration for Neuroscience clinical development programs. This role involves leading the implementation of end-to-end biomarker strategies, ensuring alignment with clinical objectives and regulatory requirements. Responsibilities include driving biomarker incorporation into study design, overseeing assay selection and validation, analyzing and interpreting biomarker data, managing biospecimen strategy, and serving as a liaison between Precision Measures and Clinical Development. The role requires a PhD with significant industry experience in drug discovery, development, and biomarker implementation, preferably in Neuroscience.

What you'd actually do

  1. 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.
  2. Responsible for analysis, interpretation and reporting of fluid & tissue biomarker data in assigned NS clinical development programs and for implementing the sample retention strategy.
  3. 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.
  4. Responsible for scientific oversight of external vendors and contract laboratories, ensuring appropriate assay methodologies, data quality, and timely delivery of results.
  5. 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.

Skills

Required

  • PhD Degree
  • minimum of 6 years industry experience
  • biomarker development and implementation and clinical development
  • Fluent in written and spoken English
  • Working knowledge of the use of Microsoft suite of software products including Excel and Word

Nice to have

  • A minimum of 8 years of drug discovery & development experience is strongly preferred
  • experience with IVD or diagnostics development preferred
  • Neuroscience experience is strongly preferred
  • Exceptional analytical and critical thinking skills
  • Excellent interpersonal skills
  • Exceptional communication and presentation skills
  • Proven experience and expertise in managing in a matrix organizational structure

What the JD emphasized

  • biomarker development and implementation and clinical development is required
  • Neuroscience experience is strongly preferred
  • Exceptional analytical and critical thinking skills
  • Exceptional communication and presentation skills