Associate Director, Patient Centered Outcomes
GSK
August 22, 2026
Remote friendly (Collegeville, PA)
United States
Patient Advocacy
Key Responsibilities / Accountabilities
Endpoint Strategy and Scientific Delivery
- Develop and implement scientifically rigorous COA (Clinical Outcome Assessment) strategies for assigned assets/programmes.
- Select/adapt/develop/validate/implement COA instruments for clinical trials and/or observational studies.
- Characterize endpoints early and plan evidence generation for regulatory and reimbursement decisions.
- Apply qualitative research, psychometrics, and statistical methods to evaluate COA measurement properties.
- Contribute to COA development/validation studies, including patient experience data collection and analysis.
- Ensure quality and timely delivery of Measurement Sciences COA deliverables.
Digital Measures and Innovation
- Support digital measures and technology-enabled endpoint strategies.
- Collaborate with digital health/data science/technology partners to integrate digital endpoints into COA strategies.
- Stay current on tools/technologies and literature for digital measurement.
Cross-Functional Collaboration and Implementation
- Work with clinical operations, biostatistics, regulatory affairs, medical affairs, and others to implement COA strategies.
- Ensure PRO/COA are accurately described in protocols, SAPs, CSRs, and publications.
- Support briefing documents, health authority queries, and regulatory submissions.
Regulatory and External Engagement
- Prepare targeted questions, background docs, and scientific summaries for regulatory interactions.
- Maintain awareness of evolving FDA COA guidance and digital-measure frameworks; communicate implications.
- Support external visibility (publications, conferences, working groups) and build relationships with collaborators/vendors.
People and Capability
- Foster scientific excellence, collaboration, and continuous learning; support knowledge sharing.
- Communicate credibly with internal/external stakeholders.
Basic Qualification (Required)
- Bachelor’s degree in psychometrics, health outcomes research, epidemiology, biostatistics, public health, behavioural science, biomedical engineering, data science, or related.
- 5+ years relevant experience (pharma/biotech/digital health/CRO/academia) with COA/patient-centered outcomes/measurement science expertise.
- Working knowledge of FDA PFDD guidance and international frameworks (e.g., EMA reflection papers); awareness of digital-measures frameworks.
- Experience contributing to development/validation/implementation of COA instruments or digital measures in clinical trials.
- Familiarity with relevant statistics (psychometric analysis, mixed-effects models, responder analyses).
- Contributions to publications, presentations, or external working groups.
Preferred Qualification
- Advanced degree (PhD/MSc/MPH or equivalent) in related field.
- Cross-functional clinical development experience and ability to communicate complex concepts.
- Therapeutic area experience (oncology, respiratory, hepatology, infectious disease/vaccines).
Skills
- Cross-functional leadership; digital fluency; evidence-based decision making; high-impact communication; patient journey.
Endpoint Strategy and Scientific Delivery
- Develop and implement scientifically rigorous COA (Clinical Outcome Assessment) strategies for assigned assets/programmes.
- Select/adapt/develop/validate/implement COA instruments for clinical trials and/or observational studies.
- Characterize endpoints early and plan evidence generation for regulatory and reimbursement decisions.
- Apply qualitative research, psychometrics, and statistical methods to evaluate COA measurement properties.
- Contribute to COA development/validation studies, including patient experience data collection and analysis.
- Ensure quality and timely delivery of Measurement Sciences COA deliverables.
Digital Measures and Innovation
- Support digital measures and technology-enabled endpoint strategies.
- Collaborate with digital health/data science/technology partners to integrate digital endpoints into COA strategies.
- Stay current on tools/technologies and literature for digital measurement.
Cross-Functional Collaboration and Implementation
- Work with clinical operations, biostatistics, regulatory affairs, medical affairs, and others to implement COA strategies.
- Ensure PRO/COA are accurately described in protocols, SAPs, CSRs, and publications.
- Support briefing documents, health authority queries, and regulatory submissions.
Regulatory and External Engagement
- Prepare targeted questions, background docs, and scientific summaries for regulatory interactions.
- Maintain awareness of evolving FDA COA guidance and digital-measure frameworks; communicate implications.
- Support external visibility (publications, conferences, working groups) and build relationships with collaborators/vendors.
People and Capability
- Foster scientific excellence, collaboration, and continuous learning; support knowledge sharing.
- Communicate credibly with internal/external stakeholders.
Basic Qualification (Required)
- Bachelor’s degree in psychometrics, health outcomes research, epidemiology, biostatistics, public health, behavioural science, biomedical engineering, data science, or related.
- 5+ years relevant experience (pharma/biotech/digital health/CRO/academia) with COA/patient-centered outcomes/measurement science expertise.
- Working knowledge of FDA PFDD guidance and international frameworks (e.g., EMA reflection papers); awareness of digital-measures frameworks.
- Experience contributing to development/validation/implementation of COA instruments or digital measures in clinical trials.
- Familiarity with relevant statistics (psychometric analysis, mixed-effects models, responder analyses).
- Contributions to publications, presentations, or external working groups.
Preferred Qualification
- Advanced degree (PhD/MSc/MPH or equivalent) in related field.
- Cross-functional clinical development experience and ability to communicate complex concepts.
- Therapeutic area experience (oncology, respiratory, hepatology, infectious disease/vaccines).
Skills
- Cross-functional leadership; digital fluency; evidence-based decision making; high-impact communication; patient journey.