Clinical Outcome Assessments Manager

Alphanumeric Systems•Durham, NC

5d•Hybrid

About The Position

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.

Requirements

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.
Candidates must be authorized to work in the United States without current or future employer sponsorship.

Nice To Haves

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.

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.