Regulatory Framework, Compliance and Health Authority Engagement

• Co-own the regulatory strategy for digital solutions in scope, including software and device classification, the applicable frameworks (e.g. EU MDR, FDA SaMD and DHT guidance, GxP and data integrity expectations) and the evidentiary standard required for each intended use.
• Ensure development, validation and change-control activities are conducted, documented and archived to a standard that withstands health authority and inspection scrutiny, with the regulatory rationale captured prospectively rather than reconstructed after the fact.
• Co-lead the preparation of regulatory-facing documentation and responses to health authority queries, and represent the scientific and regulatory position in briefing meetings, qualification advice procedures and external consortia or working groups.
• Monitor the evolving regulatory, privacy and policy landscape for digital health technologies, clinical outcome assessments and AI-enabled solutions, and translate change into practical design standards and internal guidance for teams.
• Partner with Quality, Data Privacy, Legal and Regulatory Affairs to ensure solutions meet compliance obligations across the regions in which they are deployed.

Clinical Validity and User-Centred Design

• Understand and document the needs of HCPs regarding patients' health status outside the point of care, and patients' behaviour with regard to protocol assessments and instructions. Evidence may include published clinical guidelines, supportive study documents and practitioner consensus.
• Understand and document the needs, preferences and behaviours of patients and care-partners to achieve reliable data collection and sustained adherence to study procedures.
• Collaborate with designers to create intuitive and accessible interfaces that accommodate diverse populations, including older, unwell and digitally less confident users.

Evidence Generation and Data Collection Methodology

• Design qualitative (interviews, focus groups, consensus panels, cognitive debriefing) and quantitative (surveys, psychometric and usability studies) work to establish content validity and fitness for purpose of new solutions.
• Ensure data collection methods are non-intrusive, respect participant privacy and consent, and generate actionable insights for the digital solution in its intended use.
• Ensure analytical and reporting methods meet the requirements set forth by regulators and health technology bodies for digital solutions in clinical development.

Engagement, Adherence and Behavioural Insight

• Develop strategies to engage patients, care-partners and HCPs consistently, including personalised feedback, reminders, notification design and habit-forming mechanics balanced against participant burden.
• Apply behavioural principles of motivation and habit formation to encourage regular, accurate reporting and to support adherence to treatment and study procedures.
• Create or curate content that helps patients and care-partners understand how to report their health status, take medications, or self-administer devices, in collaboration with healthcare professionals to ensure accuracy and relevance.

Evaluation, Iteration and Governance Documentation

• Work with data scientists and analysts to define KPIs and assess solution performance in terms of engagement, compliance, data quality and clinical utility, and use those findings to refine features iteratively.
• Author and/or elicit the evidence needed to support validity, reliability and integrity of digital solutions for their intended use, including regulatory-facing documentation and responses to health authority queries.
• Represent the scientific rationale for new solutions to internal governance, study teams, external sponsors and, where appropriate, scientific congresses and publications.
• Maintain the documentation trail that evidences oversight – decisions taken, rationale, risks accepted and by whom – so that the scientific, safety and regulatory basis of each solution can be reconstructed at inspection.

Leadership, Influence and Capability Building

• Provide scientific leadership and mentorship to scientists across the Digital Science team, setting standards for methodological rigour and reviewing the work of others.
• Lead cross-functional teams without direct authority, resolving competing scientific, technical, commercial and operational priorities to decisions that can be defended on scientific and patient-safety grounds.
• Build shared standards and capability across Evinova and partner functions, and act as a recognised internal and external expert in digital measurement, remote monitoring and the regulatory context in which they operate.
• Collaborate with developers, designers, healthcare professionals and other stakeholders to align on goals and integrate scientific and behavioural insight throughout the development process.

Essential requirements

• BSc/MSc or Doctoral degree in a relevant discipline such as: health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences
• Deep working knowledge of clinical drug development, including the governance, safety and regulatory frameworks that apply across phases
• Demonstrated experience translating clinical or patient needs into the design of a data collection tool, instrument, algorithm or digital feature
• Demonstrated accountability for patient safety considerations in the design, validation or deployment of clinical data collection tools, digital health technologies or medical devices
• Working knowledge of the regulatory framework governing digital health technologies and clinical outcome assessments – including software and device classification, GxP, data integrity and privacy requirements – and the ability to apply it to design decisions
• Track record of leading cross-functional teams and influencing senior stakeholders without direct authority, including in governance and decision-making forums
• Experience providing scientific oversight, review or mentorship to other scientists
• Programme leadership skills, with the ability to oversee several development workstreams in parallel and hold teams accountable to agreed standards and timelines
• Conceptual, analytical and critical thinking
• Ability to challenge the status quo, take ownership and hold self and others accountable
• Highly efficient: able to navigate ambiguity and address problems in a fast-paced environment;