Digital Science, Patient and Device Safety Director - Evinova

Role : Digital Science, Patient and Device Safety Director Location: Cambridge UK Salary: Competitive + Excellent Benefits Evinova is a health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside. Through our application of science-based expertise, evidence-led rigour, and human experience-driven insight, our digital solutions are deliberately designed so that everyone can reach better health outcomes together. Evinova is a health-tech business within the AstraZeneca Group. Digital health, the intersection of healthcare, technology, data and analytics has the potential, according to the World Health Organisation to improve health systems and outcomes when implemented equitably, inclusively and responsibly. Digital Health is a key enabler of AstraZeneca’s science-led growth strategy. At Evinova, our experience and expertise in digital health science enables us to now embed digital health solutions at scale across R&D. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. What you'll do As the Digital Science, Patient and Device Safety Director , you will set the scientific direction for, and hold oversight of, the scoping, design, development, testing and performance documentation of new digital solutions supporting clinical development – ensuring each solution is scientifically defensible, safe for the patients who use it, compliant with the applicable regulatory framework, user-centred and effective in sustaining engagement. Here are some key responsibilities you might have: 1. Innovation Strategy, Portfolio Oversight and Concept Definition: Own the innovation roadmap for patient-, care-partner- and HCP-facing digital solutions, setting scientific direction and prioritisation across the portfolio and securing endorsement at Evinova and R&D governance forums. Provide scientific oversight of the concept-to-commitment gate, holding teams to a consistent standard of intended-use definition, evidence expectation, safety consideration and regulatory positioning before investment decisions are taken. Identify and prioritise opportunities for new digital functionalities or products (e.g. RPM module, dosing diary, etc), working from disease and treatment landscape analysis, toxicity profiles, clinical guidelines, unmet monitoring needs and portfolio strategy. Define the intended use, target population, decision context and value proposition for each proposed solution, and articulate these in concept documents, business cases and stakeholder-facing materials. Assess build-versus-adopt options by evaluating existing instruments, item libraries, devices and sensors against the intended use before proposing de novo development. 2. Scientific Oversight of Instrument, Algorithm and Functionality Development: Lead the development of new measurement content and modules – item selection or de novo/bespoke item drafting, recall windows, response scales, branching logic, assessment frequency and burden optimisation. Specify scoring algorithms, thresholds, alerting rules and escalation pathways, and define how outputs are surfaced to patients, care-partners, site personnel and treating physicians. Translate scientific requirements into clear specifications and user stories for Product, Design and Engineering, and review builds against intent through configuration and testing cycles. Set and enforce the design standards applied across the portfolio – for measurement content, scoring, thresholds and escalation logic – and act as final scientific reviewer where a proposed deviation carries safety or regulatory consequence. 3. Patient Safety Oversight and Risk Management: Act as the accountable scientific lead for patient safety in the design of digital solutions, ensuring that symptom capture, thresholds, alerting rules and escalation pathways are clinically appropriate and support – rather than delay or displace – clinical judgement. Establish and maintain the risk management framework for new digital functionalities, covering risk classification, foreseeable failure modes, mitigations and safety-relevant testing, in partnership with Patient Safety, Clinical, Quality and Regulatory functions. Define how safety-relevant information captured remotely is handled – adverse event signal detection, reporting obligations, site notification requirements, and the boundary between remote monitoring and medical advice – and ensure this is reflected in solution design and study documentation. Ensure solutions are safe for the populations that will actually use them, including older, unwell and digitally less confident participants, so that safe use does not depend on a level of digital fluency they may not have. Oversee post-deployment surveillance of digital solutions, ensuring issues are triaged, escalated and remediated, and that lessons learned are fed back into design standards across the portfolio. 4. 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. 5. 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. 6. 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 act