Clinical Outcome Assessments Manager

Now Hiring:
Clinical Outcome Assessments Manager - ViiV Healthcare Durham, NC | Remote or Onsite Normal Business Hours / Core Hours Hourly Pay: $50.00 - 54.00

I'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.

• 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.

• 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.

• Advanced degree (PhD, MSc, MPH or equivalent).
• Experience with in 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.