A leading pharmaceutical company is seeking an Associate Clinical Development Medical Director based in Dublin, Ireland. This role involves providing clinical and medical leadership for pivotal trials and ensuring adherence to high safety standards and data quality. Qualified candidates should hold an MD or equivalent, with a preference for training in cardiology. The position offers the opportunity to impact clinical trial strategies and streamline recruitment effectively within the clinical landscape. #J-18808-Ljbffr
A prominent pharmaceutical company is seeking an Associate Director for Clinical Quality Assurance to oversee and provide quality assurance for clinical trials. You will ensure compliance with health authority standards and proactive leadership in QA strategies within clinical teams. Candidates must hold a degree in life sciences and have extensive experience in regulated activities. This role offers a hybrid working environment with opportunities for personal and professional growth in a dynamic setting. #J-18808-Ljbffr
Summary The Functional Excellence Director for site monitoring leads the strategic and operational advancement of field monitoring strategic capabilities across Novartis Global Clinical Operations. This role is pivotal in embedding functional excellence, harmonizing monitoring practices, and driving innovation across global hubs and country teams. It supports the Monitoring Excellence Head and collaborates closely with the Central Monitoring Head to ensure alignment with RBQM principles and enterprise-wide transformation goals. Location: London, UK or Dublin, Ireland and Barcelona, Spain About The Role Key responsibilities Define and implement excellence strategies across key monitoring roles (CRA, CPM, CRAM/MSOM, SPM, Study Lead) to both streamline and strengthen monitoring at Novartis. Embed risk-based approaches in all monitoring practices and ensure a clear connection between field monitoring activities and the IQRMP process. Lead capability development for field-based staff, ensuring the function is equipped to operate in an agile, RBQM model. Lead transformation programs involving multiple geographies and therapeutic areas to strengthen and modernize trial monitoring. Act as a champion for innovation, identifying opportunities for advancements and staying ahead of industry trends. Serve as a strategic advisor to senior leadership on field excellence and capability gaps. Promote the implementation and champion of digital tools and advanced analytics to strengthen field monitoring processes. Partner with Compliance to identify and implement process improvements across field monitoring. Essential Requirements ≥ 8 years of recent pharmaceutical industry experience, with previous experience in global strategy and/or clinical research, in a Pharmaceutical Industry, CROs, or regulatory agency. Strong leadership skills in a global setting and proven ability to develop high performing teams and diverse profiles. Strong understanding of clinical trials and evolving regulatory expectations for trial monitoring. Experience in building a new capability or transforming significantly an existing capability. Proven ability to build effective partnerships with internal and external partners. Effective influencing, negotiation and conflict resolution skills, with an enterprise mindset and demonstrated ability to drive for aligned solutions. Desirable Requirements Aptitude for data analytics and critical thinking skills. Demonstrated leadership in innovation for processes, technologies and ways of working, with a focus on sustainable and scalable solutions. Digital Savviness. 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? Learn more 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
Summary LOCATION: London, UK; Dublin, Republic of Ireland; Barcelona, Spain ROLE TYPE: Hybrid Working 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 Health Authority requirements, internal standards and full adherence to patients’ safety, rights and well‑being. Key Responsibilities Proactively provide QA leadership to the business strategy for assigned programs/trials by ensuring considerable organizational 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 & Preventive 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/Master’s). 7 years of involvement in regulated activities (GCP/Pharmacovigilance, 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. Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally. #J-18808-Ljbffr
A leading pharmaceutical company is seeking a Functional Excellence Director for site monitoring. This role will lead strategies to enhance monitoring practices and ensure innovation across global clinical operations. Candidates should possess 8+ years of experience in the pharmaceutical industry, strong leadership skills, and a proven track record of successful capability development. Join us to drive meaningful advancements in clinical trials and patient care in Dublin. #J-18808-Ljbffr
Summary Accountable for all country clinical/medical aspects associated with programs/trials by providing clinical strategic and tactical leadership. Gathers, informs, and acts on clinical/medical/scientific insights for clinical trial concept sheets/protocols, Informed Consent Forms (ICFs) and other relevant clinical documents to optimize clinical trial implementation. Drives the identification and involvement of qualified investigators with greatest recruitment potential, identifies clinical recruitment hurdles and drives clinical recruitment activities to overcome these hurdles. Accountable for adherence to safety standards and clinical data quality in the country by providing general clinical/medical support for trial related safety findings. In close collaboration with other line functions (e.g., clinical trial operations, Medical Affairs and Patient Engagement) actively contributes to successful allocation, fast clinical trial start‑up, timely recruitment, early identification of potential delays, and development and implementation of mitigation plans. About The Role Job Title: Associate Clinical Development Medical Director Primary Location: Barcelona, Spain Other Locations: Dublin, Ireland; London, UK Relocation Support: This role is based in Barcelona, Spain, Dublin Ireland or London, UK. Novartis is unable to offer relocation support: please only apply if accessible. Make your impact by providing clinical and medical leadership for pivotal trials—aligning feasibility with real‑world practice, accelerating start‑up, and safeguarding patient safety and data quality across the country. You’ll partner with investigators, site teams, regulatory bodies, and internal functions to streamline recruitment and resolve trial challenges while offering clear scientific guidance that optimizes protocols and enhances patient engagement. Job Description Provides Clinical Development and indication expertise specific to Country, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned time‑lines. Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country. Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions. Decides on site/Country‑specific scientific/clinical/medical content of the Informed Consent Form (ICF) as needed and ensures appropriateness of patient suitable language. Provides scientific/clinical/medical expertise during interactions with Country external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.). Develops clinical/medical trial plans taking the broader ecosystem into account for assigned programs/trials to ensure successful trial implementation, which includes: Provides robust indication, compound, and protocol training. Leverages innovation in clinical trial planning and decides on clinical/medical recruitment strategy and implementation based upon physician interviews, analysis of competitive trials, and patient engagement. Gathers, informs, and acts on insights from clinical trial Investigators/site staff, Medical Experts, patients, and payers, with internal stakeholders at the Country level with the goal to optimize clinical trial implementation. Supports planning, implementation, and follow‑up of scientific/clinical/medical components of Regulatory Authority inspections and internal audits. Reviews and resolves Country trial‑related scientific/clinical/medical issues/questions. If necessary, initiates the discussion with the Global Clinical Development team. Role Requirements MD/DO or equivalent, with training in cardiology preferred. Knowledge and clinical training in siRNA desirable. Protocol Execution Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial. Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care. Ability to assess the feasibility of implementing the protocol based on Country medical practice and sound understanding of the overall Clinical Development Plan. Demonstrates a high level of understanding of the protocol to train others, including site personnel. Demonstrates an understanding of the protocol to evaluate compliance on the part of the Investigator/site staff/study participant and any patient safety issues. Demonstrates an understanding of Regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials. Demonstrates current knowledge of relevant Country regulations and compliance requirements and communicates to Global teams as required. Demonstrates knowledge of applicable SOPs, policies, procedures, and guidance documents. Expertise to represent the company as safety expert for clinical trials to external Regulatory and compliance bodies such as Regulatory Authorities, Health Boards, and REB/EC. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. 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) Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook #J-18808-Ljbffr
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
