Overview Summary. LOCATION: London, UK, Dublin, Rep of Ireland, Barcelona, Spain ROLE TYPE: Hybrid Working. The Associate Director, Clinical Quality Assurance (QA) will provide Quality oversight for the end-to-end clinical process for the clinical trials under responsibility to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to patients’ safety, rights and well-being. Responsibilities Proactively provide QA leadership to the business strategy for assigned programs/trials by ensuring considerable organization awareness (e.g. Interrelationship of departments and business priorities). Drive implementation of quality strategy within Global Clinical Team (GCT) / Clinical Trial Team (CTT) under responsibility Regularly monitor the implementation of the annual Quality Plan pertaining to the assigned programs/studies Ensure adequate oversight of proactive quality risk management process in the overseen areas including quality risk assessments and submission/inspection readiness activities and ensure that Clinical Trial Process (CTP) are in control Provide robust and clear quality oversight in the following areas of clinical development: Support/collaborate with key stakeholders (e.g., Country Development Quality (CDQ), Development Units (DUs), GCT and/or CTT members) to ensure that risks are detected and remediated. Support core governance for quality incident management for critical and major deviations pertinent to the programs being assigned and ensure timely escalation when required. Provide Good Clinical Practice (GCP) guidance to day-to-day questions arising from Clinical trials deliverables. Collaborate with Country Development QA and External Service Providers (ESP) QA to drive initiatives relevant to internal monitoring and outsourced activities Quality oversight. Lead inspections preparation and facilitation in collaboration with other QA groups within Research & Development Quality (RDQ). Support audits and inspections follow-up activities including Corrective & preventative Actions (CAPA) preparation. Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct. Active participation in continuous improvement initiatives (including Work streams) and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability Be QA point of contact for the defined trials and attend the meetings and ensure quality is embedded in the decision taking processes. Essential Requirements Bachelor’s degree in life science or healthcare field required. Advanced degree or equivalent education/degree in life sciences/healthcare preferred (PhD/MD/ PharmD/ Masters). 7 years of involvement in regulated activities (GCP/ Pharmacovigilance (PV)), clinical development and/or QA positions. Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development. Ability to work independently and in a global/matrix environment. 3 or more years’ experience in managing projects. Strong skills in GCP, quality and/or clinical development Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join Our Novartis Network Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits And Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) #J-18808-Ljbffr
A global healthcare leader is seeking an Associate Director in Clinical Quality Assurance to oversee quality for clinical trials in Ireland. This role demands a Bachelor's degree in life sciences, 7 years of regulated experience, and ability to manage projects. Key responsibilities include providing QA leadership and ensuring compliance with health authority requirements. This position supports a hybrid working environment and offers the opportunity to impact patient care positively. #J-18808-Ljbffr
Join to apply for the Principal Clinical Data Scientist role at Novartis Ireland 1 day ago Be among the first 25 applicants Join to apply for the Principal Clinical Data Scientist role at Novartis Ireland Get AI-powered advice on this job and more exclusive features. Summary We are seeking a Principal Clinical Data Scientist responsible and accountable for managing all Data Management /Coding /CDD/DAP aspects of several studies, a medium to large sized project or project level activities at a consistently high standard. Summary We are seeking a Principal Clinical Data Scientist responsible and accountable for managing all Data Management /Coding /CDD/DAP aspects of several studies, a medium to large sized project or project level activities at a consistently high standard. This position is a key collaborator and strategic partner with stakeholders ensuring that pharmaceutical drug development plans in Novartis Development are executed efficiently with timely and high quality deliverables. Conceptualize and implement, in a scalable way, appropriate training delivery models and platforms for end-to-end deliverables. Follows and oversees -Good Clinical Practices (GCP), data-handling procedures & guidelines. Ensuring consistency across assigned program to aid efficiencies for submissions as well as participates in the review of clinical research protocols, reports and statistical analysis plans. Leads quality deliverables across platforms. Develops simple and reproducible strategies to ensure quality deliverables. About The Role Major accountabilities: Lead functional activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. Co-ordinate activities of Data Managers either internally or externally. Make data management decisions and propose strategies at study or project level. Ensure application of consistent data management processes, influence increased standardization and documentation across assigned project/programs -Comply with company, department and industry standards and processes. Provide and implement data Management solutions; ensure knowledge sharing. Leads process and training deliverables within multiple platforms, franchises or therapeutic areas. Develops strategies to ensure effective training and knowledge retention. Progresses towards complete, compliant, agile and simple end to end processes and effective training (Protocol/Measure through Analysis and Reporting). Representative in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response. Act as subject matter expert (SME) or, as assigned, lead process improvement/non clinical project initiatives. Develops risk Mgmt strategies to prevent data quality/coding issues from derailing projects -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Minimum Requirements Degree / Masters qualified in a relevant area Ideally 9+ years’ experience in Drug Development with at least 8 years' in Clinical Data Management Experience working across several end to end studies Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines Excellent understanding of clinical trials methodology, GCP and medical terminology Proven ability to interrogate and view data through various programming/GUI techniques. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Novartis Ireland by 2x Get notified about new Clinical Scientist jobs in Dublin, County Dublin, Ireland . 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A leading pharmaceutical company in Dublin is seeking a Senior Principal Clinical Data Scientist to oversee data management for medium to large clinical studies. The ideal candidate will have over 9 years of drug development experience, with significant expertise in Clinical Data Management. Responsibilities include leading functional activities, coordinating data management efforts, and developing risk management strategies. This position plays a critical role in ensuring timely and quality deliverables in drug development projects. #J-18808-Ljbffr
Senior Principal Clinical Data Scientist We are seeking a Senior Principal Clinical Data Scientist responsible and accountable for managing all Data Management /Coding /CDD/DAP aspects of several studies, medium to large sized projects or project level activities at a consistently high standard. Summary This position is a senior key collaborator and strategic partner with stakeholders ensuring that pharmaceutical drug development plans in Novartis Development are executed efficiently with timely and high quality deliverables. Conceptualize and implement, in a scalable way, appropriate training delivery models and platforms for end-to-end deliverables. Follows and oversees Good Clinical Practices (GCP), data-handling procedures & guidelines. Ensuring consistency across assigned program to aid efficiencies for submissions as well as participates in the review of clinical research protocols, reports and statistical analysis plans. Leads quality deliverables across platforms. Develops simple and reproducible strategies to ensure quality deliverables. About The Role Lead functional activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. Co-ordinate activities of Data Managers either internally or externally. Make data Mgmt decisions and propose strategies at study or project level. Ensure application of consistent data Mgmt processes, influence increased standardization and documentation across assigned project/programs – comply with company, department and industry standards and processes. Provide and implement data Mgmt solutions; ensure knowledge sharing. Leads process and training deliverables within multiple platforms, franchises or therapeutic areas. Develops strategies to ensure effective training and knowledge retention. Progresses DO towards complete, compliant, agile and simple end to end processes and effective training (Protocol/Measure through Analysis and Reporting). Drives towards agreed deliverables, proactively addressing potential issues before they become problematic – build and maintain effective working relationship with cross‑functional teams, able to summarize and discuss status of deliverables and critical data Mgmt aspects. Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response. Act as subject matter expert (SME) or, as assigned, lead process improvement/non clinical project initiatives. Develops risk Mgmt strategies to prevent data quality/coding issues from derailing projects. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt - Distribution of marketing samples (where applicable). Minimum Requirements Degree / Masters qualified in a relevant area. Ideally 9+ years’ experience in Drug Development with at least 8 years' in Clinical Data Management. Experience working across several end to end studies. Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines. A background of coaching and mentoring team members as required, ensuring that data management associates on the individual programs are aware of the risks, priorities, goals and impact of the work contribution. Excellent understanding of clinical trials methodology, GCP and medical terminology. Proven ability to interrogate and view data through various programming/GUI techniques. Commitment to Diversity & Inclusion We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis Helping people with disease and their families takes more innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally. #J-18808-Ljbffr
Senior Director, External Expert Engagement – Standards & Excellence Novartis Ireland – Join to apply for the Senior Director, External Expert Engagement – Standards & Excellence role. Summary Step into a high-impact leadership role as Senior Director, External Expert Engagement – Standards & Excellence at Novartis, where you will drive business excellence in the External Expert Engagement (EEE) Center of Excellence. You will be accountable for the strategic design, integration, and continuous improvement of global standards, processes, training, and business systems supporting external expert engagement across Global and International Medical Affairs. Your work will ensure governance clarity, operational scalability, and performance transparency, enabling cross-functional alignment and digital integration with Legal, ERC, IT, and Compliance stakeholders. Location Barcelona, Spain / Dublin, Ireland Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsibilities Lead the definition, refinement, and implementation of global standards, SOPs, and external expert engagement processes. Ensure ongoing review and alignment of processes with regulatory requirements, internal policies, and business needs. Partner with Governance and Operations leads to translate standards into scalable workflows and ensure consistent execution across regions. Oversee monitoring activities to track process adherence and quality performance. Drive the development and deployment of global training programmes for expert engagement stakeholders and support teams. Oversee content design strategy and coordinate outsourcing or central delivery of training materials. Promote knowledge sharing, best practice documentation, and onboarding toolkits to build capability and ensure operational consistency. Serve as business owner for expert engagement systems (e.g., HIP / ENGAGE), partnering with IT and system teams on enhancements and compliance integration. Oversee compliant data aggregation and regulatory reporting across jurisdictions, collaborating closely with Legal and governance functions. Define and lead execution of performance measurement frameworks and dashboards to support enterprise-level transparency and decision-making. Essential for the Role Master’s degree in Life Sciences, Business, Legal, or a related discipline. 12+ years of experience in pharmaceutical operations, governance, process excellence, or global operations management. Demonstrated success in designing and deploying enterprise processes and performance frameworks. Strong background in cross-functional stakeholder engagement and matrix collaboration. Experience managing or overseeing operational reporting, systems integration, or analytics. Proven ability to influence change, drive simplification, and lead global initiatives. Proven leadership skills with project management and people management experience, including direct leadership of large teams and complex multi-functional teams. Excellent English language skills, both written and spoken. Desirable for the Role Additional certifications in process excellence, training, or digital systems (e.g., Lean, Agile, Lean Six Sigma). Analytical mindset with ability to translate data into operational insights, and strategic thinking with strong process and systems orientation. Commitment To Diversity & Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Learn more: https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Senior Level Director Employment Type Full-time Job Function Business Development and Sales Industry Pharmaceutical Manufacturing #J-18808-Ljbffr
A global pharmaceutical company is seeking a Senior Director, External Expert Engagement – Standards & Excellence in Dublin. This leadership role is crucial for driving business excellence in the External Expert Engagement Center of Excellence. Responsibilities include ensuring compliance with global standards, leading cross-functional teams, and promoting organizational efficiency. Required qualifications include a Master's degree and over 12 years in pharmaceutical operations, alongside proven leadership and stakeholder engagement skills. This position offers a full-time commitment in a collaborative environment. #J-18808-Ljbffr
Patient Centered Outcomes HTA, TA Director As part of International HEOR & PCO in International Value & Access, the Patient Centered Outcomes (PCO) HTA, TA Director within the HEOR TA teams, in partnership with HEOR leads co‑leads the PCO reimbursement strategy that enables measurements of patient centered outcomes to support robust payer value propositions and evidence for HTAs, optimizing international access for prioritized Novartis assets. About The Role The PCO HTA TA Director will oversee one therapeutic area (e.g., CRM, immunology, oncology, or neurosciences) and their responsibilities will span multiple assets/indications. They will support and guide other members of the HEOR TA team in input or development of plans such as Health Technology Assessment Strategy Plans and Integrated Evidence Plans. Key Responsibilities Co‑lead with the HEOR TA lead the development, delivery, and communication of a compelling PCO reimbursement strategy within the HTAP (Health Technology Assessment Strategy Plan), IPAS (Integrated Product Access Strategy), 1BP (One Brand Plan) and aligned with the Integrated Evidence Plan (IEP). In partnership with the PCO COE, Global Program Teams, HEOR Leads, HTA Evidence Synthesis, Access, Medical Affairs, and AQS Biostat, ensure that the PCO measurement strategy includes patient reported outcomes and health utilities of relevance for international HTAs and payers into the clinical development program. Participate in and co‑lead projects on behalf of the OnePCO Alignment Forum to ensure PCOs critical for HTAs and payers are included in clinical trials, non‑interventional studies and real‑world studies for select assets and coordinate with countries to ensure alignment on local HTA and payer needs. Drive understanding of HTA requirements for PCO, health utility assessment, and adoption of standards and best practices by key markets. Lead health state valuation projects via development and management of Time Trade‑Off (TTO) or Standard Gamble (SG) studies where appropriate. Assist in scientific discussions with HTA agencies, particularly scientific advice from entities such as EU HTA JSC, NICE, CADTH for PRO/PCO endpoints, MCIDs, and by preparing appropriate briefing documents and dossiers to ensure a robust patient value proposition is included. Develop strategic scientific communication plans, including submission and presentation of research in peer‑reviewed journals and scientific/methodological congresses. Engage with external thought leaders, identify research collaborations/partnerships, and represent Novartis with external stakeholders (academic institutions, HTA agencies…) to monitor and shape the external environment with respect to patient centered outcomes research and evolving evidentiary standards for utility endpoints, ensuring awareness of these changes for Novartis. Lead above‑brand research projects/initiatives to pilot innovative methodologies for value demonstration and elevate internal standards/best practices within International Value and Access and at Novartis with cross‑functional partners. Essential Requirements 8+ years of Pharma Industry experience with 5+ years in HEOR roles in pharmaceutical companies or consulting, with at least 3 years demonstrating specific leadership of health utility projects. Advanced Degree in a relevant field. Experience evaluating, developing and validating PRO/PCO instruments to meet HTA reimbursement requirements. In‑depth understanding of key patient centered outcomes measurement systems – e.g., EuroQoL, Quality Metric Short‑Form measures, HUI, etc. Ability to lead in a cross‑functional environment. Ability to manage multiple priorities in a rapidly changing environment. Ability to work collaboratively to leverage other HEOR capabilities (strategy, regions, countries, COE PCO). Desirable Requirements Ph.D., M.D., MBA, MSc or equivalent. Strong external interfaces and network: KOLs, clinical research & scientific groups, payers, and policy organizations. Experience conducting and evaluating PCO measures from conceptualization through negotiation with international health authorities and experience in HTA submissions. Location This role can be based in the UK (London) but also in Dublin, Ireland or Basel, Switzerland. Benefits Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook. Commitment to Diversity & Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture. Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards. #J-18808-Ljbffr
A leading pharmaceutical firm in Dublin, Ireland is seeking a TA Director to drive the PCO reimbursement strategy and ensure effective measurement of patient centered outcomes for health technology assessments. The role requires over 8 years of Pharma experience, with strong leadership in health utility projects. The ideal candidate will collaborate across functions, guide evidence plans, and engage with external stakeholders to enhance patient outcomes research, ensuring compliance with HTA requirements. #J-18808-Ljbffr
