BSc/MSc or Doctoral degree in health services research, epidemiology, or related field.
Deep knowledge of clinical drug development and regulatory frameworks.
Experience in designing data collection tools or digital features based on clinical needs.
Accountability for patient safety in clinical data tools or digital health technologies.
Familiarity with regulatory frameworks for digital health and clinical outcome assessments.
Proven track record of leading cross-functional teams and influencing stakeholders.
Strong analytical, critical thinking, and communication skills.
Responsibilities
Own the innovation roadmap for digital solutions, ensuring scientific direction and prioritization.
Lead the development of measurement content and scoring algorithms for digital tools.
Act as the scientific lead for patient safety in digital solution design.
Co-own the regulatory strategy for digital solutions, ensuring compliance with health authority standards.
Design qualitative and quantitative studies to validate new digital solutions.
Develop strategies to engage patients and healthcare providers effectively.
Work with data scientists to define KPIs and assess solution performance.
Benefits
Hybrid work model with on-site attendance required 3 days a week.
Opportunity to lead innovative digital health solutions.
Collaborative environment with cross-functional teams.
Mentorship and leadership opportunities within the Digital Science team.
Engagement with cutting-edge regulatory frameworks and health technologies.
Full Job Description
This is a hybrid position and requires on-site attendance 3 days per week.
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 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.
7. 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.
8. 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.
9. 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; able to adapt to new ways of working
Creative, innovative, solution-focused
Strong communication skills and the ability to build relationships across scientific, technical and commercial audiences
Desirable requirements
Experience developing digital applications, particularly for wellness, health or clinical research
Experience with remote patient monitoring, ePRO/eCOA, or digital health technologies deployed in clinical trials
Knowledge of clinical outcome assessment methodology (content validity, cognitive debriefing, psychometric evaluation) and of toxicity grading frameworks such as CTCAE and PRO-CTCAE
Experience with data from multiple sources, including wearables and sensors
Therapeutic area knowledge in oncology and/or an understanding of treatment-related toxicity management
Direct experience of health authority interaction, regulatory submissions or qualification procedures involving digital endpoints, COAs or digital health technologies, and familiarity with novel digital development frameworks
Conduct of outcomes research studies and communication of study findings to internal and external audiences
Diligence - attention to detail and ability to manage a programme of concurrent activities
Resilience - ability to overcome and motivate others in the face of a changing environment
SO, WHAT'S NEXT?
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Where can I find out more?
Explore what we're building: www.evinova.com
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Apply today to bring smarter, faster clinical trials to life!
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About AstraZeneca
AstraZeneca is a British-Swedish multinational pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs. The company was formed in 1999 through the merger of Astra AB and Zeneca Group plc. AstraZeneca's products are used to treat a wide range of medical conditions, including cancer, cardiovascular disease, respiratory disease, and diabetes. The company has operations in over 100 countries and employs more than 76,000 people worldwide. AstraZeneca is committed to developing innovative medicines that improve the health and well-being of people around the world.
