Patient and Device Safety Director, Digital Science - Evinova

WHY JOIN US?Evinova is a health-tech business focused on accelerating better health outcomes by advancing digital transformation across the life sciences sector. By combining science-based expertise, evidence-led rigor, and deep human insight, we design digital solutions that enable healthcare to work better for everyone.Operating at the intersection of healthcare, technology, data, and analytics, we are helping unlock the full potential of digital health, transforming how clinical research is conducted, how care is delivered, and how patients experience healthcare. Our solutions are built to scale, driving efficiency, improving decision-making, and ultimately delivering better outcomes for patients worldwide.At Evinova, we are driven by a shared purpose to transform health through data and digital innovation. Our teams collaborate across disciplines to solve complex challenges, continuously learning and evolving in a fast-paced, high-impact environment.We also recognize the importance of flexibility and balance. Our ways of working support both individual needs and team collaboration. To foster connection and collaboration, employees are expected to work from the office three days per week, creating opportunities for in-person teamwork, innovation, and meaningful connection.This is a hybrid position and requires on-site attendance 3 days per week.What you'll doAs 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 requirementsBSc/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 sciencesDeep working knowledge of clinical drug development, including the governance, safety and regulatory frameworks that apply across phasesDemonstrated experience translating clinical or patient needs into the design of a data collection tool, instrument, algorithm or digital featureDemonstrated accountability for patient safety considerations in the design, validation or deployment of clinical data collection tools, digital health technologies or medical devicesWorking 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 decisionsTrack record of leading cross-functional teams and influencing senior stakeholders without direct authority, including in governance and decision-making forumsExperience providing scientific oversight, review or mentorship to other scientistsProgramme leadership skills, with the ability to oversee several development workstreams in parallel and hold teams accountable to agreed standards and timelinesConceptual, analytical and critical thinkingAbility to challenge the status quo, take ownership and hold self and others accountableHighly efficient: able to navigate ambiguity and address problems in a fast-paced environment; able to adapt to new ways of workingCreative, innovative, solution-focusedStrong communication skills and the ability to build relationships across scientific, technical and commercial audiencesDesirable requirementsExperience developing digital applications, particularly for wellness, health or clinical researchExperience with remote patient monitoring, ePRO/eCOA, or digital health technologies deployed in clinical trialsKnowledge of clinical outcome assessment methodology (content validity, cognitive debriefing, psychometric evaluation) and of toxicity grading frameworks such as CTCAE and PRO-CTCAEExperience with data from multiple sources, including wearables and sensorsTherapeutic area knowledge in oncology and/or an understanding of treatment-related toxicity managementDirect experience of health authority interaction, regulatory submissions or qualification procedures involving digital endpoints, COAs or digital health technologies, and familiarity with novel digital development frameworksConduct of outcomes research studies and communication of study findings to internal and external audiencesDiligence – attention to detail and ability to manage a programme of concurrent activitiesResilience – ability to overcome and motivate others in the face of a changing environmentSO, 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: Stay connected and see our impact in action: Apply today to bring smarter, faster clinical trials to life!Evinova is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. Evinova is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing View email address on click.appcast.io.#LI-HybridThe annual base pay for this position ranges from $194,147.20 - $254,818.20 USD. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted06-Nov-2026Closing Date19-Nov-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.SummaryLocation: US - Boston - MAType: Full time