Digital Science, Patient and Device Safety Director - Evinova

About the Company

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
• ● 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
• ● Knowledge of clinical outcome assessment methodology (content validity, cognitive debriefing, psychometric evaluation) and of toxicity grading frameworks such as CTCAE and PRO-CTCAE
• ● 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
• ● Why Evinova (AstraZeneca)
• ● Evinova draws on AstraZeneca's deep experience developing novel therapeutics, informed by insights from thousands of patients and clinical researchers. Together, we can accelerate the delivery of life-changing medicines, improve the design and delivery of clinical trials for better patient experiences and outcomes, and think more holistically about patient care before, during, and after treatment. We know that regulators, healthcare professionals, and care teams at clinical trial sites do not want a fragmented approach. They do not want a future where every pharmaceutical company provides its own, different digital solutions. They want solutions that work across the sector, simplify their workload, and benefit patients broadly. By bringing our solutions to the wider healthcare community, we can help build more unified approaches to how we all develop and deploy digital technologies, better serving our teams, physicians, and ultimately patients. Evinova represents a unique opportunity to deliver meaningful outcomes with digital and AI to serve the wider healthcare community and create new standards for the sector. Join us on our journey of building a new kind of health-tech business to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting-edge methods, and bringing unexpected teams together. Interested Come and join our journey Where can I find out more