Associate Director COA Methodology & Digital Measurement Science

The Associate Director, COA Methodology and Digital Measurement Science is responsible for ensuring that industry leading methods are used in the design, deployment and interpretation of Digital Measures within clinical development plans, across GSK's therapeutic portfolios. This matrix role, will engage with all members of Digital Measures and Patient Centered Outcomes teams to ensure scientific excellence and innovation are at the heart of the approach to their work. The role will be at the forefront of ensuring that GSK is industry-leading in terms of innovation of measurement science methods, in the excellence of our submission packages, and in the group's ability to positively influence the external environment.

Accountable to Head of Digital Measures and COA Methodology, the responsibilities listed below outline the scope of the position. The application of these tasks may vary, based upon evolving business needs.

Digital Measurement Science

• To facilitate the development of robust and fit for purpose Digital Measurement Plans, the successful candidate will work closely with technical and analytical experts within the DM team and key stakeholders in asset teams and other relevant functions.

• To be responsible for developing and maintaining the Digital Measurement Plan for assets where a Digital Measure is part of the planned evidence package.

• To ensure that required books of work for the Digital Measures team are correctly recorded as part of the Project Plan

• To faciliate consultations with external stakeholders (regulatory/payer, etc.) to ensure plans for the development and validation of Digital Measures maximise the likelihood of acceptance of data. This includes the direction of the preparation of comprehensive regulatory documents, including briefing books, submissions, and responses to regulatory agency inquiries (e.g., FDA, EMA, MHRA).

• To work with the Director, COA Methodology and Digital Measurement Science to install a culture of scientific excellence across the DM and PCO functions, making innovation and industry leading science to norm.

• To develop above asset strategies to advance measurement science across Clinical Outcome Assessments, including the use of world class data analytics, AI and innovative methods

• To facilitate work by DM and PCO members of project teams to ensure it is of the highest scientific quality, maximizing the probability that the evidence generated leads to successful submissions and engagements with payers.

• To understand and meet the requirements of all relevant GSK policies, SOPs and external regulations clearly and fully. To understand and comply with local codes of practice, guidelines, and laws to ensure the strictest requirements are met particularly with respect to delivery of promotional versus non-promotional activities.

We are looking for professionals with these required skills to achieve our goals:

• PhD or Master's degree in a relevant scientific discipline (e.g., Psychometrics, Health Outcomes Research, Biostatistics, Biomedical Engineering, Data Science, Clinical Psychology, Public Health, Epidemiology) or an MD/PharmD with extensive relevant experience.

• Minimum of 5 years of progressive experience in pharmaceutical R&D, biotech, digital health, or a relevant contract research organisation (CRO) with a focus on clinical research.

• Demonstrated a developing expertise in the development, validation, and implementation of digital health technologies for clinical research and/or real-world evidence generation.

• Experience with COA methodology, including PRO, ClinRO, and PerfO instrument development, validation, analysis, and interpretation of results.

• Experience of navigating the drug development process and regulatory pathways (e.g., IND/NDA/BLA submissions where COA/digital measures are key endpoints) including participating in regulatory agency meetings (including advisory committee presentations).

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

• Experience with advanced analytics, machine learning, and artificial intelligence applied to digital health data.

• Familiarity with various digital sensing modalities (e.g., accelerometry, photoplethysmography, voice analysis) and data streams for health monitoring.

• Published peer-reviewed articles and/or presented at major scientific conferences in the field of digital measures, COA, or related areas.

• Global experience and a nuanced understanding of international regulatory landscapes for digital health.

• An understanding of measurement theory, psychometrics, statistical analysis applied to clinical outcomes, and digital signal processing.

Skills & Capabilities:

• Scientific Acumen: A conceptual and practical understanding of clinical measurement, psychometrics, biostatistics, and digital health technologies.

• Communication & Influence: Strong written and verbal communication skills, with the ability to translate complex scientific and technical information for diverse audiences (scientific, clinical, regulatory, leadership).

• Collaboration & Cross-functional Influence: An ability to build strong relationships, collaborate effectively across functions, and influence without direct authority.

• Problem-Solving & Innovation: Analytical and critical thinking skills, with an ability to solve complex problems and drive innovative solutions.

• Agile Mindset: Capable of fostering an iterative and learning-oriented team environment.

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