Director, Digital Assessment

CHDI Management•Princeton, NJ

14d•$90,000 - $150,000•Hybrid

About The Position

CHDI Foundation, Inc. is a privately-funded, not-for-profit, biomedical research organization that is exclusively dedicated to rapidly discovering and developing therapies that slow the progression of Huntington’s disease (HD). Our scientists work closely with a network of more than 600 researchers in academic and industrial laboratories around the world in the pursuit of these novel therapies, providing strategic scientific direction to ensure that our common goals remain in focus. This helps bridge the translational gap that often exists between academic and industrial research pursuits and that adds costly delays to therapy development. In its role as a collaborative enabler, CHDI seeks to bring the right partners together to identify and address critical scientific issues and move drug candidates to clinical evaluation as rapidly as possible. Our activities extend from exploratory biology to the identification and validation of therapeutic targets, and from drug discovery and development to clinical studies and trials Director, Digital Assessment This position will report the Director, Outcomes Research and will be responsible for planning, coordinating and managing clinical studies in HD aimed at developing and validating digital health technologies for use in HD clinical trials. The successful candidate will: Define and execute a vision for digital assessment in Huntington’s disease research that includes active (i.e., task-based) and passive (e.g., wearable sensors) technologies. Manage a portfolio of projects focused on the use of digital assessments including surveys, data collection, and digital health technology validation. Provide scientific input on the development and selection of digital assessments for use in Huntington’s disease research, especially as endpoints in clinical trials. Conduct systematic and ongoing scientific reviews on the state of, and innovations and trends in digital assessment in Huntington’s disease and other medical conditions. Demonstrate understanding of the hardware involved in and the lifecycle of data captured by digital assessments (i.e., raw data to final metrics). Provide consultation to internal and external teams on digital assessments and implementation. Direct the analysis of data collected from digital assessments. Identify and ingest relevant datasets containing digital assessments. Oversee and assist in data management activities including data and results registration and distribution. Provide medical/scientific input and drive/contribute to the creation of relevant clinical documents and products required for the implementation, monitoring and evaluation of clinical trials/studies including protocols, case report forms, study manuals, informed consent forms, monitoring plans, communication plans, tracking tools, trainings, and other project tools as needed. 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. Work independently while leading the study teams and directing the work of team members. Proactively contribute to ongoing scientific dialog and projects for various Foundation programs. Maintain strong relationships with key stakeholders and partners in collaborative efforts (universities, government agencies, not-for-profit organizations, consortia, pharma/biotech companies). Plan and manage large multi-site clinical studies through CROs and academic/industrial collaborators. Other duties as assigned.

Requirements

M.D. or Ph.D. degree with 5+ years of in clinical research in pharma/biotech or academic settings with digital outcomes, and assessment development and/or clinimetrics.
Direct research experience using digital technologies in human research with related scholarly output (e.g., posters, manuscripts, dissertation, etc.).
Knowledge of digital assessment using active and passive approaches, including development, validation and use as endpoint measures in clinical studies.
Familiarity with and facility in the use of artificial intelligence for scientific and operational purposes.
Knowledge of FDA/EMA digital health technology, patient focused drug development, and endpoint guidance documents, as well as related qualification decisions.
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.
Experience presenting scientific results in professional contexts.
Willingness to travel domestically and internationally as needed.

Responsibilities

Define and execute a vision for digital assessment in Huntington’s disease research that includes active (i.e., task-based) and passive (e.g., wearable sensors) technologies.
Manage a portfolio of projects focused on the use of digital assessments including surveys, data collection, and digital health technology validation.
Provide scientific input on the development and selection of digital assessments for use in Huntington’s disease research, especially as endpoints in clinical trials.
Conduct systematic and ongoing scientific reviews on the state of, and innovations and trends in digital assessment in Huntington’s disease and other medical conditions.
Demonstrate understanding of the hardware involved in and the lifecycle of data captured by digital assessments (i.e., raw data to final metrics).
Provide consultation to internal and external teams on digital assessments and implementation.
Direct the analysis of data collected from digital assessments.
Identify and ingest relevant datasets containing digital assessments.
Oversee and assist in data management activities including data and results registration and distribution.
Provide medical/scientific input and drive/contribute to the creation of relevant clinical documents and products required for the implementation, monitoring and evaluation of clinical trials/studies including protocols, case report forms, study manuals, informed consent forms, monitoring plans, communication plans, tracking tools, trainings, and other project tools as needed.
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.
Work independently while leading the study teams and directing the work of team members.
Proactively contribute to ongoing scientific dialog and projects for various Foundation programs.
Maintain strong relationships with key stakeholders and partners in collaborative efforts (universities, government agencies, not-for-profit organizations, consortia, pharma/biotech companies).
Plan and manage large multi-site clinical studies through CROs and academic/industrial collaborators.
Other duties as assigned.