Now Hiring: Clinical Outcome Assessments Manager - ViiV HealthcareDurham, NC | Remote or OnsiteNormal Business Hours / Core HoursHourly Pay: $50.00 - 54.00I'm recruiting for a
Clinical Outcome Assessments (COA) Manager to support the
ViiV Healthcare Global Health Outcomes team.
This is a scientific, measurement-focused role supporting ViiV's drug development portfolio across
HIV treatment and prevention. The successful candidate will contribute to the development, validation, and implementation of
Clinical Outcome Assessment instruments and patient-centered endpoints used in clinical trials and observational studies.
This is an excellent opportunity for someone with a background in
COA, patient-reported outcomes (PRO), psychometrics, health outcomes research, or measurement science who enjoys working at the intersection of patient experience, clinical development, and regulatory strategy.
Key areas of responsibility include:- Supporting the design and execution of COA development and validation studies, including patient-experience data collection and analysis.
- Selecting, adapting, developing, validating, and implementing COA instruments for clinical trials and observational research.
- Applying qualitative research methods, psychometric principles, and statistical approaches to evaluate measurement properties.
- Supporting FDA and other health authority interactions related to COA and patient-centered endpoint strategies.
- Contributing to briefing documents, regulatory submissions, endpoint rationale, protocols, SAP language, and responses to health authority questions.
- Partnering cross-functionally with Biostatistics, Regulatory Affairs, Medical Affairs, Clinical Development, R&D, and Clinical Operations.
- Supporting publications, conference presentations, and other external scientific activities.
- Helping advance measurement-science standards and COA best practices across the portfolio.
Required qualifications:- Bachelor's degree in psychometrics, health outcomes research, epidemiology, biostatistics, public health, behavioral science, biomedical engineering, data science, or a related discipline.
- 3+ years of relevant experience within pharmaceutical, biotechnology, digital health, CRO, or academic environments.
- Demonstrated experience with Clinical Outcome Assessments, patient-centered outcomes, or related measurement science.
- Experience contributing to the development, validation, or implementation of COA instruments or digital measures in clinical trials.
- Familiarity with statistical approaches used for COA/digital endpoints, including psychometric analysis, mixed-effects models, and responder analyses.
- Working knowledge of FDA Patient-Focused Drug Development (PFDD) guidance and relevant international regulatory frameworks.
Highly desirable:- Advanced degree (PhD, MSc, MPH or equivalent).
- Experience within HIV or other infectious diseases.
- Strong clinical-development and cross-functional experience.
- Scientific publications, conference presentations, or participation in external working groups.
- Experience translating complex measurement-science concepts for diverse scientific and operational stakeholders.
Important scheduling note: The selected candidate will be required to take a scheduled break from work from
mid-December through early January.
- Employment sponsorship is not available for this position. Candidates must be authorized to work in the United States without current or future employer sponsorship.
- No third-party agency or vendor submissions. We are only considering candidates applying directly for this opportunity. Please do not submit resumes on behalf of candidates.
If your background includes
COA development/validation, PROs, psychometrics, patient-centered outcomes, or measurement science within clinical development, I'd love to connect.
