Patient and Device Safety Director, Digital Science - Evinova

AstraZeneca•Boston, MA

3d•Hybrid

About The Position

Evinova is a health-tech business advancing digital transformation across the life sciences sector. The Patient and Device Safety Director, Digital Science, sets scientific direction and provides oversight for the scoping, design, development, testing, and performance documentation of digital solutions supporting clinical development. The role ensures solutions are scientifically defensible, safe for patients, compliant with applicable regulations, user-centred, and effective at sustaining engagement. The Director owns the innovation roadmap for patient-, care-partner-, and HCP-facing digital solutions; defines concepts and intended uses; and provides scientific oversight of instrument, algorithm, and functionality development. The role is accountable for patient-safety oversight and risk management, co-owns regulatory strategy, and supports clinical validity, user-centred design, evidence generation, data collection methodology, engagement, and performance evaluation. It also 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. The annual base pay range is $194,147.20–$254,818.20 USD. The position offers a short-term incentive bonus opportunity and eligibility to participate in an equity-based long-term incentive program. Benefits include a qualified retirement program (401(k)), paid vacation and holidays, paid leaves, and medical, prescription drug, dental, and vision coverage, subject to plan terms.

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 regulatory frameworks for digital health technologies and clinical outcome assessments, including software and device classification, GxP, data integrity, and privacy requirements, and ability to apply them 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 agreed 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 navigate ambiguity and address problems efficiently 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 toxicity grading frameworks such as CTCAE and PRO-CTCAE.
Experience working 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 interactions, 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 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, ensuring intended use, evidence expectations, safety considerations, and regulatory positioning are defined.
Identify and prioritise opportunities for new digital functionality or products using disease and treatment landscapes, toxicity profiles, clinical guidelines, unmet monitoring needs, and portfolio strategy.
Define intended use, target populations, decision context, and value propositions, and communicate them in concept documents, business cases, and stakeholder materials.
Evaluate build-versus-adopt options for 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 participant burden.
Specify scoring algorithms, thresholds, alerting rules, escalation pathways, and how outputs are presented to patients, care-partners, site personnel, and treating physicians.
Translate scientific requirements into specifications and user stories for Product, Design, and Engineering, and review builds during configuration and testing.
Set and enforce portfolio-wide scientific design standards and serve as final scientific reviewer for deviations with safety or regulatory consequences.
Act as the accountable scientific lead for patient safety in digital solution design, ensuring symptom capture, thresholds, alerts, and escalation pathways are clinically appropriate and support clinical judgement.
Establish and maintain risk management frameworks with Patient Safety, Clinical, Quality, and Regulatory functions, including risk classification, foreseeable failure modes, mitigations, and safety testing.
Define the handling of remotely captured safety information, including adverse-event signal detection, reporting obligations, site notifications, and boundaries between remote monitoring and medical advice.
Ensure solutions can be used safely by their intended populations, including older, unwell, and digitally less confident participants.
Oversee post-deployment surveillance, issue triage, escalation, remediation, and the application of lessons learned to portfolio design standards.
Co-own regulatory strategy, including software and device classification, applicable frameworks, and evidence standards for each intended use.
Ensure development, validation, and change-control activities are documented and archived to withstand health authority and inspection scrutiny, with regulatory rationale captured prospectively.
Co-lead regulatory documentation and health authority responses, and represent scientific and regulatory positions in briefing meetings, qualification procedures, consortia, and working groups.
Monitor changes in digital health, privacy, policy, clinical outcome assessment, and AI regulation, translating them into design standards and internal guidance.
Partner with Quality, Data Privacy, Legal, and Regulatory Affairs to ensure compliance across deployment regions.
Understand and document HCP needs regarding patients’ health outside points of care, and patient behaviours concerning 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 on intuitive, accessible interfaces for diverse users, including older, unwell, and digitally less confident populations.
Design qualitative and quantitative research, including interviews, focus groups, consensus panels, cognitive debriefing, surveys, psychometric studies, and usability studies.
Ensure data collection is non-intrusive, respects privacy and consent, and produces actionable insights for the solution’s intended use.
Ensure analytical and reporting methods meet regulatory and health technology body requirements for digital solutions in clinical development.
Develop engagement strategies, including personalised feedback, reminders, notification design, and habit-forming mechanics balanced against participant burden.
Apply behavioural principles to encourage regular, accurate reporting and support treatment and study-procedure adherence.
Create or curate content that helps patients and care-partners report health status, take medication, or self-administer devices, working with healthcare professionals to ensure accuracy and relevance.
Work with data scientists and analysts to define KPIs and evaluate engagement, compliance, data quality, and clinical utility, using results to refine features.
Author or elicit evidence supporting validity, reliability, and integrity, 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 accountable 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, resolving competing scientific, technical, commercial, and operational priorities on defensible scientific and patient-safety grounds.
Build shared standards and capability across Evinova and partner functions and act as an internal and external expert in digital measurement, remote monitoring, and related regulation.
Collaborate with developers, designers, healthcare professionals, and other stakeholders to align goals and integrate scientific and behavioural insight.