Covance seeks an Associate Director who specializes 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 conduct qualitative and quantitative studies, 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. Flexible location Western Europe.
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.
Job Responsibilities and Skills
The candidate will be able to:
- manage complex proposals and project teams
- develop study designs, analysis plans, reports, and publications
- manage his/her capacity and utilization across multiple projects
- manage proposal and budget writing
- participate in sales calls, capabilities pitches, and bid defenses
- interact effectively with teammates across service areas
- effectively mentor more junior teammates
- effectively work with internationally remote and culturally diverse teammates
The candidate will possess a graduate degree in clinical science, psychology, psychometrics, health services research, public health, business, or other relevant discipline.
- 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 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 using advanced statistical methods • conduct psychometric analyses using classical and modern test theory
- 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 candidate will offer experience in a PRO consulting environment and have expertise and experience in clinical trial study design, selection of COAs, 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.