Clinical Outcomes Specialist (San Francisco, CA)

Summary
The Clinical Outcomes Specialist provides expertise in the selection, modification, and development of neuropsychological endpoints across programs. This role involves contributing to clinical study design, operational plans, data quality monitoring, and cross-functional collaboration to ensure high-quality outcomes in clinical trials.
 

Requirements

• Advanced degree (Ph.D. strongly preferred) in neuropsychology or a related scientific discipline (e.g., MS, MD, PharmD, PsyD).

• Active professional licensure in psychology (or equivalent) preferred.

• 2+ years of experience conducting neuropsychological assessments (post-doctoral experience considered).

• 2+ years of experience in clinical outcomes research within life sciences, research organizations, academia, or governmental agencies.

• Expertise in neuropsychological and behavioral assessment development, psychometrics, and analysis.

• Familiarity with outcomes research in pediatric, neurodegenerative, and/or rare disease therapeutic areas.

• Experience training or teaching psychological assessments preferred.

• Strong qualitative and quantitative skills in study design, data analysis, and interpretation.
   

Responsibilities

• Provide technical expertise in neurocognitive outcomes to support endpoint selection, modification, or development.

• Assess and generate evidence on the psychometric properties, clinical meaningfulness, and regulatory gaps of neuropsychological outcomes.

• Develop and execute operational plans, including translation, cultural adaptation, rater training, protocol implementation, and trial data monitoring.

• Conduct quality monitoring of neuropsychological endpoints, including data review for early and late-stage studies.

• Contribute to the design, authoring, and review of clinical study protocols and process manuals.

• Collaborate cross-functionally with teams in Clinical, Operations, Data Management, Biometrics, Regulatory, and Medical Affairs.

• Manage vendors to deliver outcomes aligned with timelines and business objectives.

• Work with clinical trial sites and site raters to ensure proper delivery and collection of trial outcome assessments.

Department: Direct Clients
This is a full time position