Associate Director Validation Jobs Near Me

The Associate Director, Measurement Sciences is a scientific role within Measurement Sciences responsible for delivering high-quality endpoint strategies and measurement science support across GSK's drug development portfolio. Working under the direction of the Core Portfolio Lead, the Associate Director applies technical expertise to plan, develop, and implement Clinical Outcome Assessment (COA) and digital measure strategies that are scientifically robust, patient-centred, and fit-for-purpose.

The Associate Director contributes to integrated evidence plans across a range of development programmes, which may include assets in oncology, respiratory, hepatology, and infectious disease and vaccines. They work cross-functionally with clinical development, regulatory affairs, biostatistics, medical affairs, and clinical operations to ensure that patient-centric and digital endpoints are defined, validated, and implemented appropriately in clinical trials. The role requires strong scientific grounding, attention to regulatory standards, and a commitment to advancing measurement science to capture the patient voice and digital health signals in demonstrating the value of GSK's products.

Endpoint Strategy and Scientific Delivery

• Develop and implement high-quality, scientifically rigorous COA strategies for assigned assets and development programmes, ensuring alignment with development objectives, regulatory requirements, and evidence-generation goals.
• Guide the selection, adaptation, development, validation, and implementation of COA instruments in the context of clinical trials and/or observational studies.
• Ensure that endpoint approaches are well-characterised early in the development lifecycle, with clear plans to generate evidence supporting regulatory and reimbursement decisions.
• Apply qualitative research methods, psychometric principles, and statistical approaches to evaluate the measurement properties of COA.
• Contribute to the design and execution of COA development and validation studies, including patient experience data collection and analysis.
• Assume accountability for the quality and timely delivery of Measurement Sciences outputs, including deliverables associated with COA strategies.

Digital Measures and Innovation

• Support digital measures and technology-enabled endpoint strategies across assigned programmes.
• Collaborate with digital health, data science, and technology partners to support the integration of digital endpoints into COA strategies and development programmes where relevant.
• Stay current on emerging tools, technologies, and scientific literature relevant to digital measurement in drug development.

Cross-Functional Collaboration and Implementation

• Work cross-functionally with clinical operations, biostatistics, regulatory affairs, medical affairs, and other stakeholders to ensure COA strategies are implemented correctly in clinical trials.
• Ensure that PRO/COA are accurately described in study protocols, statistical analysis plans, clinical study reports, and publications.
• 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.

Regulatory and External Engagement

• Support regulatory interactions for assigned assets 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 for digital measures, and communicate implications to cross-functional teams.
• Support external scientific visibility through contributions to publications, conference presentations, and participation in industry working groups.
• Build productive working relationships with external collaborators, academic partners, and vendors.

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 Measurement Sciences best practices, templates, and knowledge resources.
• Represent Measurement Sciences in relevant asset team meetings, study teams, and governance forums as appropriate.

People and Capability

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

Why You?
Basic Qualification
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.
• 5+ years of relevant experience in pharmaceutical, biotechnology, digital health, CRO, or academic settings, with demonstrated expertise in COAs, patient-centred outcomes, or related measurement science disciplines.
• Working knowledge of FDA PFDD Guidances 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 Qualification
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: oncology, respiratory, hepatology, or infectious disease and vaccines.
• Strong written and verbal communication skills, with the ability to engage effectively with stakeholders across operational and scientific functions.

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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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