Director, Assessment Science

Job Location

The position will be based in Princeton, N.J. with occasional travel to New York City and Los Angeles.

Job Reports To

This position will report to a Vice President/Unit Leader and will be responsible for planning, coordinating & managing clinical studies in HD aimed at developing and validating clinical scales and performing clinimetric research.

Job Description

  • Provide scientific input on the development and selection of assessments for use in non-interventional research
  • Provide scientific input on the development of assessments for use as endpoints in clinical trials
  • Manage a portfolio of projects and contribute to assessment develop programs across HD domains of interest including cognition, function, motor, and behavioral/psychiatric
  • Plan and manage large multi-site clinical studies through CRO’s and academic/industrial collaborators
  • Provide medical/scientific input and drive/contribute to the creation of relevant clinical documents required for the implementation, monitoring and evaluation of clinical trials/studies
  • Review work produced by project site teams and ensure that studies are completed on time and within budget, monitor recruitment progress
  • Manage collaborative relationships with clinical investigators globally to ensure timely execution of clinical studies
  • Manage fiscal performance of the studies and maintain close control of study costs
  • Work independently while leading the study teams and directing the work of team members
  • Proactively contribute to ongoing scientific dialog for various Foundation programs

Minimum Requirements:

  • M.D. or Ph.D. degree
  • At least 5 years of direct experience in clinical research in pharma/biotech or academic settings with focus on scale development, assessment training, and/or clinimetrics
  • Demonstrate knowledge in the area of patient-reported outcome (PROs), observer-reported outcome (ObsROs), clinician-reported outcome (ClinROs), and performance outcome (PerfO) measures, including development, validation and use as endpoint measures in clinical studies
  • Proven ability in clinimetric analysis and interpretation
  • Demonstrate knowledge of electronic clinical outcome assessment (eCOA) development processes, including conversion of paper and pencil to electronic versions
  • Demonstrate knowledge of digital endpoints
  • Knowledge of FDA/EMA endpoint guidance and CDISC standards
  • Demonstrate knowledge of clinical trial components and support functions
  • Knowledge of FDA and ICH regulations regarding Good Clinical Practice (GCP)
  • CRO, contract management, and budgetary experience
  • Excellent interpersonal skills, and both written and oral communication skills

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