Wgr-585 | 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 settings 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 rigor, 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.

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 utilization 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.Ensure 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.Lead 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, actioning 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, analyze 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 participate 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 demonstration of compliance with regional requirements.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 ORBachelors degree in a related discipline, plus 5 years clinical practical experience.Extensive knowledge of digital health technologies in drug development.Extensive knowledge of devices utilized 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.

Date Posted: 16-dic-2024
Closing Date: 10-ene-2025

AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

#J-18808-Ljbffr