Research And Development Specialist

Key Responsibilities

• Provide clinical teams with the information necessary for the appropriate incorporation of PRO measures in clinical studies.
• Provide information and guidance in choosing appropriate PRO instruments for clinical studies.
• Determine availability of selected PRO instruments and their translations for inclusion in clinical trials; and to implement any validation studies required; and to provide PRO training and materials for trial investigators.
• Ensure appropriate PRO data capture methods (including ePRO) and processes are implemented.
• Oversee psychometric analyses and work with statisticians on PROs included in protocols, statistical analysis plans, and clinical study reports.
• Prepare relevant sections of documentation and communication for regulatory agencies in support of submission activities.
• PRO analyses and sections of dossiers for HTA submissions.
• Abstracts and manuscripts presenting PRO results from clinical studies.
• Identify, evaluate and manage projects with researchers and PRO vendors external to the company, including but not limited to qualitative research, cultural validation studies, validation studies for special populations, and quantitative analyses.
• Manage budgets and contracts for PRO projects.
• Ensure PRO activities are captured in a shared electronic PRO repository.

Required Skills and Experience

• A Master’s degree in the field of psychology, psychometrics, sociology, health economics, biostatistics, epidemiology, public health or health services research.
• A minimum of 4 or more years of Patient Reported Outcomes experience.
• A minimum of 2 or more years of experience in project management.
• Experience in the strategy, conceptual basis, methodology and application of PRO and other health outcome measures in the context of clinical studies.
• Experience with the development, psychometric evaluation and selection of PRO instruments used in clinical studies.
• Experience managing budgets.
• Ability to work effectively as a member of cross-functional teams.
• Excellent oral, written and presentation skills.
• Ability to work in a matrix environment.

Preferred Skills and Experience

• An advanced degree, PhD or PharmaD.
• Experience with the drug development process in the pharmaceutical industry.
• Regulatory understanding in negotiating PRO label claims.
• Working knowledge Patient Focused Drug Development initiatives, the 2009 FDA "Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" and other relevant guidance and best practices.
• Experience with ePRO.
• Capable of leading and influencing teams and driving decisions.