Clinical Outcome Assessments Manager

Alphanumeric Systems Inc; Durham (NC); Hybrid; USD 69,000 - 74,000; Full time

Job summary

ViiV Healthcare seeks a Clinical Outcome Assessments (COA) Manager to support the Global Health Outcomes team in Durham, NC, with remote or onsite options. You will develop, validate, and implement COA instruments and patient-centered endpoints used in clinical trials and observational studies, emphasizing PRO, psychometrics, and measurement science.

Requirements include 3+ years in pharma/biotech, a related bachelor’s degree, and familiarity with FDA PFDD guidance; strong statistical and

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 PFDD guidance and relevant international regulatory frameworks.

Responsibilities

• 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.

Skills

COA

PRO

Psychometrics

Health outcomes

Measurement science

Education

Bachelor's degree in related discipline

Job description

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 aClinical Outcome Assessments (COA) Manager to support theViiV Healthcare Global Health Outcomes team.

This is a scientific, measurement-focused role supporting ViiV's drug development portfolio acrossHIV treatment and prevention. The successful candidate will contribute to the development, validation, and implementation ofClinical Outcome Assessment instruments and patient-centered endpoints used in clinical trials and observational studies.

This is an excellent opportunity for someone with a background inCOA, 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.