Clinical Safety Science Lead
Location: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.
Introduction
We’re building out a best-in-class team to support R&D as well as routine care setting with digital solutions including digital therapeutics to ensure that our products have the right scientific foundations to provide impactful insights towards better patients’ care.
Evinova
Evinova is a health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside. Through our application of science-based expertise, evidence-led rigour, and human experience-driven insight, our digital solutions are deliberately designed so that everyone can reach better health outcomes together. Evinova is a health-tech business within the AstraZeneca Group.
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Digital health, the point at which healthcare, technology, data and analytics converge, is the subject of great promise, with the World Health Organisation believing it has the potential to improve health for everyone. At AstraZeneca, we’ve been working hard to make this a reality, with the years of experience we have accumulated enabling us to now embed digital health at scale across R&D. To achieve our goal of improving patient experience and outcomes AstraZeneca has Digital Health as one of the top 4 strategic priorities for the company.
The role
The Clinical Safety Science Lead responsibilities include, but are not limited to, providing clinical expert leadership and knowledge to Evinova developed and marketed device and digital solutions. This individual will act as Clinical Safety Science Lead for assigned projects/products during development and on the market, including enabling their utilisation in clinical studies for investigational medicinal products or in a healthcare setting when on the market.
Accountabilities
Provide ongoing leadership and safety and clinical subject matter expertise to device and digital projects/products. Ensures input of suitable medical safety and clinical evidence expertise to the SaMD product design process.
Lead and be responsible for the medical and scientific input to the device and/or digital program’s design and development
Contribute to Risk Management File (RMF) through the analysis of hazard assessments
Provide clinical sign-off
Contribute to developing clinical device and/or digital documents
Leading the creation and update of the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) based on post-market surveillance (PMS) data
Lead Post Market Surveillance, such as authoring the PMS Plan
Responsible for carrying out all vigilance-related activities for Software as a Medical Device (SamD), including receipt of post-market data, vigilance data analysis, actionaling post market clinical follow-up plan, field safety corrective actions, trend reporting, and/or medical devices reporting.
Ensure Clinical Safety Science contribution is aligned with regulations.
Review, analyse and interpret safety data obtained to lead device and digital development
Take accountability and lead resolution of safety issues and mediate cross-functional agreement related to assigned devices or digital assets.
Participate in cross-functional process improvement or other initiatives related to digital and devices
Contribute to the generation of Evinova’s position on innovative use of digital health solutions and medical devices in medicinal product development and post market activities
Actively participates in Issue Management Team where investigation of an incident requires assessment of the safety or performance of a medical device or device constituent; responsible for assessing issues/cases utilizing clinical & medical expertise to determine potential impact to patients/users
Actively participate in SamD audits & notified body assessments, supporting demonstrateion of compliance with regional requirments
Provide subject matter expertise to establishment, review, approval, and maintenance of relevant clinical & safety procedures within the SaMD Quality Management System (QMS)
Maintain oversight of medical device, digital health regulations, and local requirements that impact patient safety and/or require implementation
Act as the primary point of escalation for any risks and issues identified relevant to the assigned projects/products
Work with internal teams to monitor the overall performance of processes & technology within the assigned area. Track & monitor agreed key performance indicators, oversee the delivery of Corrective and Preventative Actions to time and Quality, and act on data or trends identified through the Quality and Risk Management processes
Serve as SME to provide operational and/or strategic safety input and guidance to Evinova clients in their utilization of digital and device development Evinova cross functional teams
Education, Qualifications, Skills and Experience
Essential for the role
Combination of academic training and practical experience in device and/or digital development experience or related knowledge/experience. This may consist of:
Masters degree in a related discipline, plus 8 years practical clinical experience OR
Bachelors degree in a related discipline, plus 5 years clinical practical experience
Extensive knowledge of digital health technologies in drug development.
Extensive knowledge of devices utilised to administer medicine or monitor patients.
Previous demonstrated experience of regulated drug and/or device development or equivalent, and experience with major Health Authority interactions (US or Ex-US) particularly in the field of safety science
Professional experience in clinical development, patient safety and/or quality management systems relating to medical devices and device constituents
Knowledge and understanding of global clinical and post-market safety requirements and an ability to balance with industry standards to achieve business goals.
Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
Strong communication, negotiation, and problem-solving skills.
Ability to work effectively in cross-functional teams and manage multiple priorities.
Excellent organizational and project management skills.
Strong attention to detail and ability to work independently.
Creative, innovative, and solution-focused
Curious, embraces new ways of problem solving, new ideas, and new ways of working
Desirable for the role
Advanced degree is preferred.
Experience of being nominated as Responsible for Compliance as defined in medical device regulations (such as (EU) 2017/745)
Prior experience with phase 3 design including end of phase 2 health authority interactions is preferred.
A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
Ability to work strategically within a complex, business critical and high-profile development program.
Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components.
Understanding of strategic and tactical roles and deliverables of Global Regulatory Strategy in digital health technologies for drug development and investigation
Diligence - attention to detail and ability to manage a program of concurrent activities
Resilience - ability to overcome and motivate others in the face of a changing environment
Why Evinova ?
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.
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