📢 Now Hiring: Clinical Outcome Assessments Manager ? ViiV Healthcare

 Now Hiring: Clinical Outcome Assessments Manager - ViiV Healthcare

 Durham, NC | Remote or Onsite

 Normal Business Hours / Core Hours

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.

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 settings, with demonstrated expertise in COAs, patient-centered outcomes, or related measurement science disciplines.

 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.