Patient and Device Safety Director, Digital Science - Evinova

AstraZeneca•Boston, MA

5d•$194,147 - $254,818•Hybrid

About The Position

Evinova is seeking a Digital Science, Patient and Device Safety Director to set scientific direction and oversee the scoping, design, development, testing, and performance documentation of digital solutions for clinical development. The role is accountable for ensuring that solutions are scientifically defensible, safe for patients, compliant with applicable regulatory frameworks, user-centred, and effective in sustaining engagement. The Director owns the innovation roadmap for patient-, care-partner-, and HCP-facing digital solutions; defines intended use, target populations, decision contexts, and value propositions; and provides scientific oversight of portfolio investment decisions. The role leads the design of measurement content, algorithms, thresholds, alerts, and escalation pathways, translating scientific requirements into specifications and reviewing solutions through development and testing. The role establishes patient-safety and risk-management approaches, oversees post-deployment surveillance, and partners with Patient Safety, Clinical, Quality, Regulatory, Data Privacy, and Legal teams. It co-owns regulatory strategy, supports regulatory documentation and health-authority engagement, and monitors changes in the digital health regulatory and policy landscape. The Director also guides user-centred design and evidence generation, evaluates solution performance, maintains governance documentation, and provides scientific leadership, mentorship, and cross-functional influence. This is a hybrid position requiring on-site attendance three days per week.

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 governance, safety, and regulatory frameworks 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 digital health technology and clinical outcome assessment regulation, including software and device classification, GxP, data integrity, and privacy requirements, and 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, including overseeing several development workstreams in parallel and holding teams accountable to standards and timelines.
Conceptual, analytical, and critical-thinking skills.
Ability to challenge the status quo, take ownership, and hold self and others accountable.
Ability to work efficiently through ambiguity and address problems in a fast-paced environment, while adapting to new ways of working.
Creative, innovative, and solution-focused approach.
Strong communication skills and ability to build relationships across scientific, technical, and commercial audiences.

Nice To Haves

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, including content validity, cognitive debriefing, and 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 understanding of treatment-related toxicity management.
Direct experience with health-authority interaction, regulatory submissions, or qualification procedures involving digital endpoints, COAs, or digital health technologies, and familiarity with novel digital development frameworks.
Experience conducting outcomes research studies and communicating study findings to internal and external audiences.
Diligence, attention to detail, and ability to manage concurrent activities.
Resilience and ability to overcome challenges and motivate others in a changing environment.

Responsibilities

Own the innovation roadmap and set scientific direction and prioritisation for patient-, care-partner-, and HCP-facing digital solutions.
Provide scientific oversight of concept-to-commitment decisions, including intended-use definitions, evidence expectations, safety considerations, and regulatory positioning.
Identify and prioritise opportunities for digital functionality or products based on disease and treatment landscapes, toxicity profiles, clinical guidelines, unmet needs, and portfolio strategy.
Define intended use, target population, decision context, and value proposition for proposed solutions; document these in concepts, business cases, and stakeholder materials.
Assess build-versus-adopt options for existing instruments, item libraries, devices, and sensors.
Lead development of measurement content and modules, including item selection or drafting, recall windows, response scales, branching logic, assessment frequency, and burden optimisation.
Specify scoring algorithms, thresholds, alerting rules, and escalation pathways, and determine how outputs are presented to relevant users.
Translate scientific requirements into specifications and user stories for Product, Design, and Engineering; review builds during configuration and testing.
Establish and enforce portfolio design standards and serve as final scientific reviewer when deviations have safety or regulatory implications.
Act as accountable scientific lead for patient safety in digital-solution design and ensure remote symptom capture and escalation support rather than displace clinical judgement.
Establish and maintain risk-management frameworks for digital functionality, including risk classification, foreseeable failure modes, mitigations, and safety-relevant testing.
Define handling of safety-relevant remotely captured information, including adverse-event signal detection, reporting obligations, site notifications, and boundaries between monitoring and medical advice.
Ensure solutions can be used safely by intended populations, including older, unwell, and digitally less confident participants.
Oversee post-deployment surveillance, issue triage, escalation, remediation, and incorporation of lessons into design standards.
Co-own regulatory strategy, including software and device classification, applicable frameworks, and evidence standards for intended uses.
Ensure development, validation, change-control, documentation, and archiving meet health-authority and inspection expectations, with regulatory rationale recorded prospectively.
Co-lead regulatory documentation and health-authority responses, and represent scientific and regulatory positions in meetings, qualification procedures, consortia, and working groups.
Monitor regulatory, privacy, and policy developments in digital health, clinical outcome assessments, and AI-enabled solutions, translating changes into internal standards and guidance.
Partner with Quality, Data Privacy, Legal, and Regulatory Affairs to support compliance across deployment regions.
Understand and document HCP needs regarding patient health outside the point of care, and patient behaviours relating to protocol assessments and instructions.
Understand and document patient and care-partner needs, preferences, and behaviours to support reliable data collection and sustained adherence.
Collaborate with designers to develop intuitive and accessible interfaces for diverse users.
Design qualitative and quantitative research to establish content validity and fitness for purpose of new solutions.
Ensure data collection is non-intrusive, respects privacy and consent, and provides actionable insights for the solution's intended use.
Ensure analytical and reporting methods meet regulator and health-technology-body requirements for digital solutions in clinical development.
Develop engagement strategies for patients, care-partners, and HCPs, including feedback, reminders, notification design, and habit-forming mechanics balanced against participant burden.
Apply behavioural principles to encourage regular, accurate reporting and adherence to treatment and study procedures.
Create or curate accurate and relevant patient and care-partner content about reporting health status, medication use, and device self-administration, in collaboration with healthcare professionals.
Work with data scientists and analysts to define KPIs and assess engagement, compliance, data quality, and clinical utility; use findings to refine features.
Author or elicit evidence supporting validity, reliability, and integrity of digital solutions, including regulatory-facing documentation and responses to health-authority queries.
Present scientific rationale to internal governance, study teams, external sponsors, and, where appropriate, scientific congresses and publications.
Maintain documentation of decisions, rationale, accepted risks, and decision-makers so the scientific, safety, and regulatory basis can be reconstructed at inspection.
Provide scientific leadership and mentorship to Digital Science scientists, set methodological standards, and review others' work.
Lead cross-functional teams without direct authority and resolve competing scientific, technical, commercial, and operational priorities.
Build shared standards and capability across Evinova and partner functions and act as an expert in digital measurement, remote monitoring, and relevant regulation.
Collaborate with developers, designers, healthcare professionals, and other stakeholders to align goals and integrate scientific and behavioural insight.