Clinical Outcome Assessments Manager

Expected Deliverables Expected deliverables may include COA development plans, validation study materials, qualitative interview guides, cognitive debriefing materials, psychometric analysis input, endpoint rationale summaries, protocol and SAP language, vendor briefing materials, evidence summaries, and regulatory engagement and response content related to patient-centered endpoints. The Patient-Centered Outcomes Manager is a scientific role within the CLIENT Global Health Outcomes team responsible for delivering high-quality clinical outcome assessment strategies and measurement science support across CLIENT S drug development portfolio to support the needs of multiple stakeholders.

Job Description:
Job Title: Clinical Outcome Assessments Manager
Location: Durham, NC 27701, Onsite/Remote
Duration: 1 Year (09/28/2026 to 09/24/2027)

Shift: Normal business hours/ Core hours - This can be onsite or remote

Please note that the selected candidate would need to take a break from work from mid-December through early January.

Job Description:
The Patient-Centered Outcomes Manager is a scientific role within the CLIENT Global Health Outcomes team responsible for delivering high-quality clinical outcome assessment strategies and measurement science support across CLIENT S drug development portfolio to support the needs of multiple stakeholders. Working under the direction of the Pipeline Lead, the Manager applies measurement science expertise to support the development, validation, and implementation of COA instruments outside, and contributes to the planning and execution of regulatory engagement strategies related to COAs.

The Manager contributes to integrated evidence plans across a range of development programmes across HIV treatment and prevention. They work cross-functionally with clinical development, regulatory affairs, biostatistics, medical affairs, and clinical operations to ensure that patient-centric endpoints are defined, validated, and implemented appropriately in clinical trials and observational studies. The role requires strong scientific grounding, attention to regulatory standards, and a commitment to advancing measurement science to capture the patient voice in demonstrating the value of CLIENT S products.

Key Responsibilities / Accountabilities
COA Strategy and Scientific Delivery

• Contribute to the design and execution of COA development and validation studies, including patient experience data collection and analysis.
• Guide the selection, adaptation, development, validation, and implementation of COA instruments in the context of clinical trials and/or observational studies.
• Apply qualitative research methods, psychometric principles, and statistical approaches to evaluate the measurement properties of COA.
• Assume accountability for the quality and timely delivery of Measurement Sciences outputs, including deliverables associated with COA strategies.

Regulatory and External Engagement

• Support regulatory interactions for assigned assets and cross portfolio by preparing targeted questions, background documents, and scientific summaries related to COA strategies.
• Maintain awareness of evolving regulatory guidance, including relevant FDA COA-related Guidances and frameworks, and communicate implications to cross-functional teams.
• Support external scientific visibility through contributions to publications and conference presentations.
• Build productive working relationships with external collaborators, academic partners, and vendors.

Cross-Functional Collaboration and Implementation

• Work cross-functionally with biostatistics, regulatory affairs, medical affairs, R&D, and other stakeholders to ensure COA strategies are aligned to asset and cross-portfolio priorities.
• Contribute to briefing documents, responses to health authority queries, and regulatory submissions related to endpoint strategy.
• Partner with internal teams to promote consistent and appropriate use of measurement science standards and best practices.

Portfolio Contribution and Scientific Standards

• Support application of established methodologies, reusable endpoints, and standardised processes across the portfolio to promote consistency and efficiency.
• Contribute to the development and maintenance of COA best practices, templates, and knowledge resources.

People and Capability

• Contribute to building a culture of scientific excellence, collaboration, and continuous learning within the Global Health Outcomes team.
• Support knowledge sharing and capability development initiatives across the organisation.
• Communicate clearly and credibly with internal and external stakeholders on measurement science topics.
• Pursue continuous learning to stay current with evolving methodologies, regulatory guidance, and digital health innovation.

Expected Deliverables

• Expected deliverables may include COA development plans, validation study materials, qualitative interview guides, cognitive debriefing materials, psychometric analysis input, endpoint rationale summaries, protocol and SAP language, vendor briefing materials, evidence summaries, and regulatory engagement and response content related to patient-centered endpoints.
• The successful candidate will be expected to work independently on assigned deliverables, manage competing timelines across multiple assets, proactively identify risks or dependencies, and communicate progress clearly to the Pipeline Lead and relevant study teams.

Why You?
Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals.

• Bachelor's degree in psychometrics, health outcomes research, epidemiology, biostatistics, public health, behavioural science, biomedical engineering, data science, or a related discipline.
• 3+ years of relevant experience in pharmaceutical, biotechnology, digital health, CRO, or academic settings, with demonstrated expertise in COAs, patient-centered outcomes, or related measurement science disciplines.
• Working knowledge of FDA PFDD Guidance and relevant international regulatory frameworks (e.G., EMA reflection papers), and awareness of evolving frameworks for digital measures and digital endpoints.
• Experience contributing to the development, validation, or implementation of COA instruments or digital measures in clinical trials.
• Familiarity with statistical methods relevant to the evaluation of COA and/or digital endpoints, including psychometric analysis, mixed-effects models, and responder analyses.
• Record of contribution to scientific publications, conference presentations, or external working groups.

Preferred Qualifications
If you have the following characteristics, it would be a plus:

• Advanced degree (PhD, MSc, MPH, or equivalent) in psychometrics, health outcomes research, epidemiology, biostatistics, public health, behavioural science, biomedical engineering, data science, or a related discipline.
• Experience working cross-functionally in a clinical development environment, with the ability to communicate complex measurement science concepts to diverse audiences.
• Experience in one or more of the following therapeutic areas is preferred: HIV or other infectious diseases.
• Strong written and verbal communication skills, with the ability to engage effectively with stakeholders across operational and scientific functions.