We are presently hiring an Associate Director, PRO for our Gaithersburg, MD, or San Diego, CA location. This position is also open to remote work.
The Associate Director will specialize in patient-reported outcomes (PROs) and clinical outcomes assessment (COAs) to develop business, manage projects, and manage client relationships in our consulting group. The Associate Director works collaboratively with expert teams (colleagues and clients) to develop and validate measures, assist in implementing PROs in clinical trials, and develop and present publications and posters. A specific background in PRO development and validation or the application of PRO assessments in clinical trials is desired.
Responsibilities include managing or directing patient-reported outcomes studies and other consulting projects; ensuring client needs, promised timelines, and budgets are met; managing staff members; and ensuring that the department’s financial objectives are met, including helping to develop new and repeat business. This position is located in Gaithersburg, MD, San Diego, CA, or at the employee’s location (i.e., remote work is an option for the appropriate, self-driven candidate). Travel is estimated at 5% to 10% and international travel may be required at times.
Required: The candidate will possess a PhD in clinical science, psychology, psychometrics, health services research, public heath, business, or other relevant discipline.
The ideal candidate will have a solid understanding of advanced design and analysis techniques used in both qualitative and quantitative research, including ability to:
• review literature, PRO instruments, and PRO labels, and conduct gap analysis
• develop questionnaires and conduct expert interviews and patient interviews
• analyze and interpret data
• conduct psychometric validation of newly developed or existing PRO instruments
• recommend appropriate PRO and other clinical outcomes assessments for inclusion in clinical trial protocols
• design statistical analysis plans for PROs and other clinical outcomes assessments
•The Associate Director should have at least 5 years of experience working with biopharmaceutical and/or medical device companies and have experience in PRO development and validation, PRO instrument assessment and selection, and other disciplines relevant to PRO studies.
•The Associate Director is expected to travel to meet with clients and must be able to work on evenings and weekends as necessary to meet project schedules.
The candidate will offer experience in a PRO consulting environment and have expertise and experience in clinical trial study design, selection of screening tools, development of study protocols and statistical analysis plans, collection and analysis of study data, and have an interest in, or experience with, instrument development to support labeling claims in the US and EU. The candidate must possess skills in and experience with consulting for pharma and biotech clients and the ability to clearly communicate findings and recommendations in an analysis plan or study report.