Senior Scientist/Associate Director, Patient-Centered Outcomes (PCO)
Job Summary
Our Senior Scientist/Associate Director, Patient-Centered Outcomes (PCO) lead and support qualitative and mixed-methods research projects focused on clinical outcome assessment (COA) development and content validation, PRO/COA measurement strategy and regulatory advising, patient/caregiver surveys, and other patient-centered qualitative research to support the evaluation of therapeutics within our growing Health Economics and Outcomes Research (HEOR) consulting practice.
Senior Scientist/Associate Directors take responsibility for a wide range of scientific research and consulting activities, with a primary focus on qualitative research approaches. They lead project teams in developing and performing targeted or systematic review of medical literature (most frequently focusing on COA endpoints), qualitative interviewing, coding, analysis, and reporting They also prepare, support, and participate in direct interactions with the FDA and other regulatory agencies.
The PCO team at OH is passionate about working on research that brings benefits to patients and their families. We understand the relevance of measuring the right patient outcomes and patient experience and are committed to OPEN Health’s values when working on diverse PCO projects.
Essential Duties amp; Responsibilities
As part of the OPEN Health Patient Centered Outcomes (PCO) team, you’ll be responsible for activities such as:
- Providing client-facing leadership within the study design consulting process including collaborating with clients to develop research strategies that align with their objectives and research questions
- Serving as internal and external project lead throughout project life cycle
- Providing scientific oversight of study design and execution to meet client expectations and study timelines
- Managing vendor and third-party relationships to ensure sponsor satisfaction
- Creating and/or managing/leading creation of project deliverables or other assignments including study proposals, protocols, interview guides, reports, and study slides
- Conducting qualitative interviews including concept elicitation and cognitive debriefing in support of COA instrument development and evaluation
- Using qualitative analysis software (such as ATLAS.ti) to code and categorize key themes captured within qualitative interview transcripts.
- Fostering collaboration and knowledge sharing within OH Qualitative team and with other service area groups (e.g., psychometrics, real-world survey, patient engagement, etc.)
- Collaborating with the business development team to leverage existing industry relationships and advance new business opportunities for the Center of Excellence (CoE)
- Playing a key role in proposal development and project budgeting, showcasing expertise in qualitative methodologies and ensuring accurate and realistic financial plans for research projects
- Mentoring and fostering professional development of junior staff members
Experience, Skills, and Qualifications
- Master’s degree in health services research, Pharmaceutical and/or Health Outcomes, Public Health, Epidemiology, Medical Anthropology/Sociology, Pharmacoeconomics, or a related field
- 5+ years of direct experience in PCO research
- Proven experience conducting patient-centered outcomes studies and research, advanced training in study design and research methodology
- Excellent project management skills with a demonstrated ability to collaborate with and lead multidisciplinary project teams
- Ability to independently lead project design and proposal development
- Knowledge of ethical and regulatory requirements for studies with human subjects
- Strong attention to detail and superior communication skills (both written and verbal)
- Proactive, efficient, and responsiveness to shifting priorities in a team-based research consultancy setting to ensure expectations are exceeded
- Strong analytical and organizational skills; including the ability to prepare and present relevant summaries of complex materials
- Experience with qualitative data collection methods (individual interviewing, focus group facilitation, etc.) and analysis software (such as ATLAS.ti, Dedoose, or NVivo)
- Advanced proficiency in MS365 including Word, PowerPoint, Excel, Access, Outlook and Teams, with an emphasis on strong Excel proficiency
- Exceptional presentation skills, demonstrating strong analytical and organizational skills to present relevant summaries of complex materials.
- Active publication history and commitment to continue publications
- Foreign language proficiency a plus
- Experience with online questionnaire software (such as QuestionPro or Su