Associate Director, Patient Centered Outcomes

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🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $141.8k - $236.3k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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GSK

WebsiteLinkedInAll Job Openings

10,000+ employees

🏭 Manufacturing

💊 Pharmaceuticals

🏥 Healthcare

Manufacturing • Pharmaceuticals • Healthcare

GSK is a global healthcare company focused on uniting science, technology, and talent to advance pharmaceutical products and vaccines. With a commitment to innovation, GSK aims to provide solutions that help manage and prevent diseases, improving health outcomes for patients worldwide.

📋 Description

• Develop and implement scientifically rigorous Clinical Outcome Assessment strategies for assigned assets and development programmes • Guide selection, adaptation, development, validation, and implementation of COA instruments in clinical trials and observational studies • Ensure endpoint approaches are characterised early and support regulatory and reimbursement decisions • Apply qualitative research, psychometric principles, and statistical approaches to evaluate COA measurement properties • Contribute to COA development and validation studies, including patient experience data collection and analysis • Deliver high-quality and timely Measurement Sciences outputs • Support digital measures and technology-enabled endpoint strategies • Collaborate with digital health, data science, and technology partners on digital endpoints • Work cross-functionally with clinical operations, biostatistics, regulatory affairs, medical affairs, and other stakeholders • Ensure PRO/COA are accurately described in protocols, statistical analysis plans, clinical study reports, and publications • Contribute to briefing documents, health authority responses, and regulatory submissions • Support regulatory interactions and prepare scientific summaries related to COA strategies • Contribute to publications, conference presentations, and industry working groups • Build relationships with external collaborators, academic partners, and vendors • Promote reusable endpoints, standardised processes, best practices, templates, and knowledge resources • Represent Measurement Sciences in asset team meetings, study teams, and governance forums • Support scientific excellence, knowledge sharing, and capability development

🎯 Requirements

• Bachelor's degree in psychometrics, health outcomes research, epidemiology, biostatistics, public health, behavioural science, biomedical engineering, data science, or a related discipline • 5+ years of relevant experience in pharmaceutical, biotechnology, digital health, CRO, or academic settings • Demonstrated expertise in COAs, patient-centred outcomes, or related measurement science disciplines • Working knowledge of FDA PFDD Guidances and relevant international regulatory frameworks, including EMA reflection papers • 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 for evaluating 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 • Advanced degree in a related discipline is preferred • Experience working cross-functionally in a clinical development environment • Experience in oncology, respiratory, hepatology, or infectious disease and vaccines is preferred • Strong written and verbal communication skills

🏖️ Benefits

• Annual bonus • Eligibility to participate in share-based long-term incentive program • Health care and other insurance benefits for employee and family • Retirement benefits • Paid holidays • Vacation • Paid caregiver/parental and medical leave • Comprehensive benefits program for US employees