Novartis Farmacéutica

LOCATION: London, UK or Dublin, Rep of Ireland, Barcelona, Spain ROLE TYPE: Hybrid Working The Associate Director, Clinical 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. About the Role Key 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. Support 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. 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? 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? 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: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Alternative Location 1 Dublin (Country President Office (CPO , Ireland Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Associate Director Clinical Processes & Solutions Job ID REQ- Mar 19, 2025 Ireland Summary LOCATION: London, UK or Dublin, Ireland ROLE TYPE: Hybrid Working, The Associate Director Clinical Processes & Solutions is responsible for leading and driving operational and scientific excellence through clinical process improvement across the portfolio. This includes but is not limited to actively driving updates of standard operating procedures, templates, guidance, and trainings. This position also serves as a clinical representative on cross-functional governance boards and development initiatives (including other line function initiatives). About the Role Key Responsibilities: Drive the update of clinical document templates such as Clinical Trial Protocol, Investigator Brochure, Clinical Data Review, and Clinical Development Plan according to clinical guidance Participate and represent Clinical Development (CD) on important strategic cross-functional projects as defined by CD Leadership Team. Drive cross CD and Global Line Function alignment of processes as part of the deliverables of CD and drive implementation at the Unit level. Lead QA/standard operating procedure (SOP) activities within CD, which includes coordinating Subject Matter Experts (SME) identification; applying clinical applicability; performing collegial reviews of SOPs, templates and processes Can serve as a Lead SME or as an SME for clinical process-related work such as protocol deviations Drive best practices by identifying clinical training needs and development opportunities. Identify cross-functional issues, gaps and lead global process improvement work streams as applicable In collaboration with QA, responsible to implement quality initiatives as needed: inspection readiness, records tracking, support audits preparation and follow up. From a people standpoint, work with the CD to make sure that CD Leadership is informed at all points about key issues and has access to information when needed Key Performance Indicators: Clinical excellence, sharing of best practices, harmonized across Functions & Divisions High quality CD processes & successful execution of CD initiatives Well managed, effective and engaged teams Education: Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master, PharmD, or PhD strongly preferred (or equivalent) Languages: Fluent oral and written English Experience/Professional requirement: Strong understanding of Pharmaceutical Development processes 5 years technical and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia Thorough knowledge of Good Clinical Practice Strong scientific background in basic and clinical research Strong skills in leading and managing cross-functional projects with significant (visible) business impact. Act as change agent and actively generate and foster creativity and innovation in CD Leadership presence with the ability to present and interact with senior management Why Novartis?: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: You'll receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: 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? 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: IE02 (FCRS = IE002) Novartis Ireland Ltd Alternative Location 1 London (The Westworks), United Kingdom Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

LOCATION: London or Dublin ROLE TYPE: Hybrid Working, The Vendor Program Strategy Director (VPSD) acts as the Business Partner for all vendor activities with the Clinical Operational Program Head (COPH). The VPSD, in collaboration with the COPH, Portfolio Innovation Director (PID), the External Relationship Management Teams (ERMT) and Procurement defines the program vendor strategy end-to-end. The VPSD is accountable at program level for the vendor delivery across the clinical study lifecycle from study start-up, recruitment, maintenance and closeout in accordance with Good Clinical Practice (GCP), International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH), Standard Operating Procedures (SOP's), and regulations. About the Role Major accountabilities: End-to-end accountability for all supplier related activities at a program level across Global Drug Development (GDD) Portfolio Manages a program view of supplier performance relative to the defined strategy Defines and aligns program strategies in close collaboration with Alliance Lead, ERMT, PID and Procurement In collaboration with Vendor Alliance Leads, reviews geographic scope of global vendors and drives local vendor service delivery discussions with country representatives in case of gaps Understands upcoming portfolio demand within Program through COPH role (new trials, new program, Business Development and Licensing (BD&L), research collaboration) and pushes information to Vendor organization Understands and translates new service needs, in advance, and engages with Vendor Alliance Lead for vendors to be identified, qualified, and contracted to support future Programs/Trials Support activities for Health Authority (HA) inspections/Audit readiness Enables early engagement with suppliers during protocol development & feasibility stage and serves as single point of contact for Trial Vendor Management Team representative for program level strategies Key performance indicators: End-to-end Supplier Service Delivery at the Program and Trial Level - Accountable for all external clinical activities for defined program strategies. Lead supplier decision making sessions with other key internal and external partners. In collaboration with the ERMT, proactive vendor risk management, assessing trends, quality issues, and contract issues, driving suppliers quality improvement at program level Trial and Program timelines through supplier related start-up, recruitment, maintenance and closeout activities 10+ years relevant industry experience, including expertise in clinical operations leadership of multidisciplinary teams, experience management outsourced trial activities at an operational and strategic level Advanced degree in science or business with equivalent experience Demonstrated executive leadership in developing and managing external and internal strategic relationships Experience with clinical processes and associated supplier services, with excellent understanding of trial management, trial monitoring and overall integration of clinical data system and processes Strong technical and problem solving skills Excellent understanding of clinical trial methodology, GCP and medical terminology Excellent understanding of clinical development, quality & regulatory standards and policies relevant to defined services Provide thought-leading insights to the competitive environment and internal partner interfaces Outstanding skills to facilitate/optimize contribution of team members as individuals and members of cohesive team Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: 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? 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: IE02 (FCRS = IE002) Novartis Ireland Ltd Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Global Regulatory Affairs Director (Global Program Regulatory Director) Job ID REQ- United Kingdom Summary (3 days per week on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Director Novartis is seeking a Global Program Regulatory Director (GPRD) to lead global regulatory strategies for development and marketed products. This role integrates inputs from health authorities and stakeholders to meet commercial and portfolio objectives. The GPRD identifies regulatory opportunities, develops contingencies, ensures strategy execution, leads regulatory subteams, and represents Regulatory Affairs on program and cross-functional teams. About the Role Major accountabilities: Create high-quality global regulatory strategies and manage Health Authority interactions to achieve development and business objectives. Identify and communicate potential regulatory opportunities and risks, and develop mitigation strategies. Utilize regional expertise to define and execute global regulatory strategies and engage with Health Authorities. Offer strategic regulatory input on key development, labeling, and promotional documents. Oversee submission planning, guide contributing authors, and critically review submission documentation. Lead interactions with regulatory and development management and external consultants for strategic input. Provide strategic regulatory and development input into Business Development & Licensing due diligence evaluations. Maintain compliance with global regulatory requirements and internal policies, and coordinate regulatory compliance activities. Lead regulatory teams, provide feedback and coaching, and support the growth and development of subteam members. Manage regulatory submissions, portfolio transformation activities, and business and operational excellence tasks. Bachelor's or Master's in a science-based field; advanced degrees preferred. Fluent in English; additional languages are a plus. Significant experience in regulatory and pharmaceutical development (Phases I-IV). Expertise in regulatory strategy, scientific data analysis, and HA guidance. Significant experience with major submissions. Knowledge of post-marketing strategies and commercial awareness. Proven regulatory operations and compliance skills. Strong leadership and matrix management abilities. Excellent communication, influencing, and problem-solving skills. Ability to navigate organizational complexity effectively. Commitment to Diversity and Inclusion/EEO 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? 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? 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: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Job ID REQ- Global Regulatory Affairs Director (Global Program Regulatory Director)

Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) Job ID REQ- United Kingdom Summary (3 days per week on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Senior Global Program Regulatory Manager We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team.The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle. About the Role Major accountabilities: Lead the implementation of regulatory strategies and operational activities across major global regions. Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents. Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams. Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials. Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans). Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals. Develop and implement strategies to minimize review delays and regulatory clock stops. Ensure timely and compliant responses to HA queries and requests. Contribute to departmental goal setting and lead initiatives to improve regulatory processes. Ensure adherence to internal policies, SOPs, and global regulatory requirements. Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field. Significant experience in regulatory affairs within the pharmaceutical industry. Proven track record in project management and regulatory operations. Experience representing the organization in cross-functional and cross-cultural settings. Strong knowledge of clinical trials, drug development, and regulatory compliance. Excellent problem-solving, negotiation, and communication skills. Detail-oriented with the ability to manage complex regulatory projects. Skilled in risk management and working with cross-functional teams. Ability to navigate and influence Health Authority interactions. Fluency in English (written and spoken) is essential. Commitment to Diversity and Inclusion/EEO 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? 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? 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: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Job ID REQ- Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) Manage Consent Preferences Always Active If you provided your email for marketing or disease awareness purposes, you may need to provide further information to enable us to fully honor your preferences. Click here to learn more.

Global Regulatory Affairs Manager (Global Program Regulatory Manager) Job ID REQ- United Kingdom Summary (3 days per week on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Manager We are looking for an experienced and proactive Regulatory Affairs Manager to join our Global Regulatory Affairs team. This role is critical in driving regulatory strategy and managing operational activities across key regions. You will collaborate with cross-functional teams to ensure timely submissions, approvals, and compliance with global regulatory requirements, supporting the successful development and commercialization of pharmaceutical products. About the Role Major Responsibilities: Implement regional regulatory strategies in alignment with global objectives. Contribute to global regulatory planning and identify strategic gaps or risks. Lead or support Health Authority (HA) interactions, including briefing material preparation. Coordinate timely and compliant regulatory submissions across assigned regions. Review and approve Clinical Trial Applications (CTAs), Investigational New Drugs (INDs), and Risk Management Plans. Act as a liaison with local HAs (e.g. FDA, EMA) as required. Ensure timely and effective responses to HA queries and requests. Collaborate cross-functionally to align regulatory plans with business goals. Monitor and ensure compliance with internal policies and external regulations. Support or lead negotiations for regional approvals to meet project timelines. Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field. Proven experience in regulatory affairs within the pharmaceutical industry. Strong understanding of drug development and clinical trial processes. Experience in managing regulatory submissions and HA interactions. Commitment to Diversity and Inclusion/EEO 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? 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? 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: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Alternative Location 1 Dublin (NOCC), Ireland Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Location: London (The Westworks) Relocation Support: This role is based in London (The Westworks). Novartis is unable to offer relocation support: please only apply if accessible. About the Role As a Customer Experience Manager, you will play a pivotal role in enhancing customer satisfaction and driving brand loyalty. Your efforts will directly impact how customers perceive and interact with our brand, ensuring they have a seamless and positive experience at every touchpoint. By leading the development of promotional activities and collaborating with cross-functional teams, you will help shape the future of our customer engagement strategies. This is an exciting opportunity to make a significant difference in the lives of our customers and contribute to the growth of our brand. About the Role Key Responsibilities Prepare content for Integrated Brand Teams and Launch Teams to ensure cohesive brand messaging. Execute, monitor, and analyze agreed tactical plans to ensure brand growth. Lead the development of promotional activities in line with internal SOPs and Code of Conduct guidelines. Monitor and control brand budgets, forecasts, and expenses to evaluate cost effectiveness and results. Identify market insights and opportunities through customer interactions. Execute central and regional marketing activities to support brand objectives. Monitor product performance and external environment, taking corrective actions as needed. Collaborate with Marketing and Medical teams to maximize activities and identify specific needs for each patient segment within the assigned territory. Proven cross-cultural experience to effectively manage diverse teams and customer interactions. Strong project management skills to oversee and execute marketing initiatives. Expertise in operations management and execution to ensure smooth implementation of strategies. Excellent agility and adaptability to respond to changing market conditions and customer needs. Proficiency in digital marketing to enhance brand presence and customer engagement. In-depth understanding of the healthcare sector to align marketing strategies with industry standards. Strong influencing skills to effectively drive marketing strategies and initiatives. Experience in stakeholder management to build and maintain strategic partnerships. Commitment to Diversity: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: You'll receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities. If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: 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? 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: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Functional Area Marketing Job Type Full time Employment Type Regular Shift Work No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

-Understand complex and critical business problems, formulates integrated analytical approach to mine data sources, employ statistical methods and machine learning algorithms to contribute solving unmet medical needs, discover actionable insights and automate process for reducing effort and time for repeated use. To manage the implementation and adherence to the overall data lifecycle of enterprise data from data acquisition or creation through enrichment, consumption, retention, and retirement, enabling the availability of useful, clean, and accurate data throughout its useful lifecycle. High agility to be able to work across various business domains. Integrate business presentations, smart visualization tools and contextual storytelling to translate findings back to business users with a clear impact. Independently manage budget, ensuring appropriate staffing and coordinating projects within the area. If managing a team: empowers the team and provides guidance and coaching, with initial guidance from more senior leaders supervised. This is usually their first people manager experience. About the Role Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together! The Role As a Senior Principal Data Scientist in the Medical Affairs Advanced Quantitative Sciences group, you will be responsible for the discussion and implementation of data science methodologies applied to patient-level data (including various clinical, real-world, and biomarker data) across clinical development. You will combine your data science and AI skills and your scientific knowledge in biology or medicine to enrich drug development decisions in close collaboration with internal and external partners. This role offers hybrid working, requiring 3 days per week or 12 days per month in our London Office. Key Accountabilities: You will contribute to planning, execution, interpretation, validation and communication of innovative exploratory analyses and algorithms, to facilitate internal decision making. You will provide technical expertise in data science and (predictive) machine learning/AI to identify opportunities for influencing internal decision making as well as discussions on white papers/regulatory policy. You will perform hands-on analysis of integrated data from clinical trials and the real world to generate fit-for-purpose evidence that is applied to decision making in drug development programs. Your Experience Ph.D. in data science, biostatistics, or other quantitative field (or equivalent). More than 3 years experience in clinical drug development with extensive exposure to clinical trials. Strong knowledge and understanding of statistical methods such as time to event analysis, machine learning, meta-analysis, mixed effect modeling, longitudinal modeling, Bayesian methods, variable selection methods (e.g., lasso, elastic net, random forest), design of clinical trials. Strong programming skills in R and Python. Demonstrated knowledge of data visualization, exploratory analysis, and predictive modeling. Excellent interpersonal and communication skills (verbal and writing). Ability to develop and deliver clear and concise presentations for both internal and external meetings in key decision-making situations. 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? 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.

HTA Evidence Synthesis Statistician (2 open roles) Job ID REQ- Apr 28, 2025 United Kingdom Summary We are committed to fostering a source of versatile, commercially focused, and inspiring talent. As part of our ongoing quest to embody proactive thought leadership, we emphasize on sharing our enterprise strategies while remaining focused on addressing the unique country's needs as a value-added solution focused partner. Join the International HEOR & PCO Team, a pivotal partner in International Value & Access, leading with excellence the evidence generation to demonstrate the value of our innovative medicine portfolio. An opportunity has arisen for an experienced Senior HTA Statistician to apply innovative statistical approaches to complex challenges in health technology assessment (HTA). This role offers the chance to lead the evidence synthesis of patient data from clinical, observational, and real-world data studies supporting HTA submissions, in a flexible and collaborative environment. The role is responsible for leading the design and execution of evidence-synthesis for HTA submissions incl. EU HTA JCA Dossier and for health economic models. Position applies methodological and analytical expertise to predict the value of Novartis assets and develop strategies on how best to demonstrate this to external decision makers. Role will strategically and effectively communicate, and tailor generated evidence to multiple stakeholder audiences. About the Role Key responsibilities: As part of the HEOR & PCO Team: Develop core global Indirect Treatment Comparison (ITC) plan for HTA, payer and other Access stakeholder assessments, submissions, and negotiations. Lead publications associated with these to meet business objectives. Provide strategic, methodological, and analytical support to regions and top countries with adaptation of the Indirect Treatment Comparison (ITC) for local HTA submissions and support the local assessment of HTA strategy. Coordinate data requirements across evidence generations functions (Clinical Development; Medical Affairs/Biostat and HEOR & PCO) to support Pricing & Reimbursement. Set-up systems internally to proactively capture key HTA analytic requirements across key international markets to inform and optimize key internal deliverables e.g., statistical analysis plans. Track key HTA statistics priorities and sequence them aligning with resource availability and risks. Identify need for preliminary ITCs to inform value proposition, development, pricing and commercial strategic forecast and decisions. Lead and facilitate the sharing of best practices and key learnings across regions, countries and cross-functional partners. Stay on top of innovative techniques, using robust analytical techniques leveraging available clinical data and published information to inform pricing and market access strategy. Collaborate with the MA Biostats team for trial analyses, HTA challenges, and statistical analyses. Act as a Strategic Partner for key partners from HEOR & PCO and International Value & Access (Therapeutic Area Access, Pricing) to ensure alignment to brand and commercial, access and evidence strategy. Ensure optimal utilization of comparative evidence through partnership with teams generating payer & promotional materials, generating regulatory dossiers and publications. Provide mentoring and coaching support to junior members of evidence modelling teams and across function. The ideal candidate will possess a strong background in statistics, with relevant experience in HTA and clinical research. MSc/PhD in Statistics, Biostatistics, or a related field. Experience from pharmaceutical industry or life-science consultancy 6-8 years relevant experience in consultancy or pharmaceutical industry in Evidence Synthesis, Health Economics, Health Technology Assessment, or related area Strong understanding of clinical drug development and HTA-related regulations and processes Local HTA experience including experience with country HTA submissions Strong understanding of statistical methodologies for indirect treatment comparisons (ITCs) and population-adjusted indirect comparison (PAIC) Proficiency in statistical software such as R and/or SAS Strong interpersonal and scientific communication skills. Excellent problem-solving abilities and attention to detail (desirable?) Ability to lead in a matrix environment and work collaboratively in interdisciplinary cross-functional teams Location: This role can be based in the UK, London but also based in Basel, Switzerland and Dublin, Ireland. 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. Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, be-cause of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 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? 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: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Job ID REQ- HTA Evidence Synthesis Statistician (2 open roles)

Regulatory Affairs Knowledge Management Capability Lead Job ID REQ- May 30, 2025 United Kingdom Summary Job Description Summary As a member of the Knowledge & Content Management Platform team, the Knowledge Management Capability Lead contributes to the strategic vision of Regulatory Affairs and supports the digitalization and centralization of Knowledge Management in Regulatory Affairs, by overseeing one or several product(s) underlying the Capability. The Knowledge Management Capability is supporting knowledge gathering and sharing across the organization, as well as the leveraging of collaboration tools. This capability is defining the strategy for successful deployment and usage of knowledge management technologies, best practices, and advising on information structure. The capability is also supporting regulatory requirements gathering and availability, as well as advocating for an harmonized approach through the leveraging of state-of-the-art enterprise tools. The Capability should also ensure high user adoption & scale-up, and easy retrieval of information potentially leveraging Artificial Intelligence. The Knowledge Management Capability Lead is accountable to ensure that the Capability strategy delivers business benefits, and to drive harmonization and continuous improvements. About the Role Key Responsibilities Responsible to ensure alignment of a team with organizational goals and business priorities related to Knowledge Management Support the strategic vision for the Knowledge & Content Management Platform, from a Capability level Act as a Change Lead to drive system adoption, communication and training, at the capability level: implement change management strategies to ensure smooth adoption of technology initiatives Define, prioritize, and deploy an integrated capability roadmap working in close collaboration with relevant stakeholders and DDIT partners, ensuring alignment with the Knowledge & Content Management Platform, Development and Enterprise technology strategy roadmaps Represent the Capability in digital governance boards and leadership meetings across the organization and in digital networks, externally (e.g. across Industries) as needed Communicate effectively to ensure understanding and support for new technology initiatives Support continuous expansion of knowledge and foster the adoption of a digital mindset within the Regulatory Affairs team Oversee vendors at the capability level, across product(s), in collaboration with IT and the External Partnerships Teams Oversee integrations with products underlying the Capability. Ensure on-time, compliant, secure, and quality delivery of portfolio for the assigned capability/product(s), aligned with the NVS Quality Manual Contribute to the change management strategy to ensure smooth adoption of technology initiatives, as required Ensure adherence to Security and Compliance policies and procedures within the scope of the Capability, and prepare for audit readiness and inspection requirements (incl. Related mitigations or actions triggered by audits & inspections). Responsible for Product(s) within the Capability. Can act as a product manager and a product owner Ensure on time, compliant, secure, and quality delivery of portfolio for the assigned product(s), partnering with relevant IT functions. Responsible to approve product-related requirements across product(s) underlying the Capability Responsible for configuration, decision making and outcome, impacting the capability, with involvement of relevant Business Process Owner(s), business SMEs and stakeholders Provide support/resources for key projects and programs with impact to the underlying product(s), ensuring timely delivery of high-quality milestones in alignment with business requirements. 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? : Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team's 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? 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: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Leads the strategic and operational planning/ management from a clinical trial execution perspective. Complete oversight of budget and resource allocation for the assigned programs. Drives operational excellence through process improvement and knowledge sharing across the function. Fosters an empowered organization which can navigate in a matrix environment and adjust quickly to business needs. About the Role Location: London, The Westworks Hybrid Study Start-Up Strategy Collaborates with Study & Site Operations Country Leadership Team to identify innovative practices to optimize country operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact. Seeks and evaluates external knowledge and best practices to enhance overall operational excellence of country trial operations. Defines and continuously optimizes country SSU strategy in close collaboration with SSO Country Head and SSO Country/Cluster Head Portfolio. Accountable for timely start-up activities from country allocation until Green Light (ready-to-initiate-sites). Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable. Allocation, Initiation and Conduct of Trials Collaborates with SSO Country/Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments. Accountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements. Implements innovative and efficient processes which are in line with Novartis strategy. Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times. People and Resource Management Hiring, training, development, and retention of Study Start-Up team. Resource management and reporting of Study Start-Up Team. Ensures associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectives. Manages and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functions. Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates who drive us each day to reach our ambitions. Be a part of this mission and join us! 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. GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Associate Director, Statistical Programming Job ID: REQ- Date: Jan 28, 2025 Location: United Kingdom Summary The Early Development, Associate Director, Statistical Programming, is responsible for all statistical programming aspects of one or more drug development programs or indication programs within the Early Development space. As a program lead, the Associate Director ensures cross-functional collaboration within and outside AQS and decision-making for assigned trials/programs in drug life cycle management. They ensure that the assigned trials/programs are adequately resourced and oversee all aspects of programming, quality, and regulatory compliance. This key leadership position ensures the efficient execution of trial/program level plans, delivering high-quality results on time. A thorough understanding of the drug development process, experience in regulatory activities, and expertise in statistical reporting, along with a proven track record in operational or functional leadership, is required. About the Role Lead SP activities for multiple clinical trials within a program or an indication/disease area. Experience in one of the TA areas: Immunology, Cardiovascular & Metabolic Diseases, and Neuroscience is a must. Coordinate activities of internal/external programmers. Make statistical programming decisions and propose strategies at the program or indication/disease level. Develop scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s). Responsible for allocating resources within a program and ensuring resource sharing between programs to meet Advanced Quantitative Science and organizational goals. Recruit, mentor, and nurture statistical programmers. Conduct performance appraisal of direct reports, as applicable. Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and summarize and discuss the status of deliverables and critical programming aspects with them (timelines, scope, resource plan). Maintain up-to-date advanced knowledge of programming software (e.g., SAS/R) as well as industry requirements (e.g., CDISC, eCTD, Define.xml), attend functional meetings and training. Represent SP (Early Development) at indication or program-level in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g., CDISC). Experience: In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met. BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree. Must also be fluent in English. Must have early development experience, ideally in Oncology. Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders. Expert in SAS or R programming, including the development and validation of deliverables within a Statistical Programming environment, and the creation of advanced MACROs and/or functions. Matrix or people management of approximately 6-15 internal or external programmers. Depending on the role, may act as a functional/operational manager of associates or may be an individual contributor with no direct reports. Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs. At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including the coordination of large teams of internal and/or external programmers. Ideally, 10+ years of industry experience, with at least 6 years in a programming or statistical role. At least 3 years of line management or equivalent leadership experience, such as matrix management (applicable for people managers only).

As a Global Medical Affairs Director, you will contribute to the development and implementation of the medical strategy across the life-cycle of our assets in ASCVD with a focus on evidence generation and execution as well as providing the foundation for a compelling and cohesive scientific narrative. In addition, you will provide medical leadership for GMA and cross-functional teams in addressing and delivering strategic pre-launch, launch and post-launch activities directed at clinical adoption and access for patients. About the Role Job Description Serve as a disease area scientific and medical expert for internal customers/stakeholders, e.g., GMA supportive functions (Real World Evidence, SciComms, Field Medical), Clinical, Biomedical Research, Marketing, Novartis local medical organizations, as well as external customers e.g. medical experts (MEs), healthcare system stakeholders and patient advocacy groups. For assigned Medical Affairs studies (Phase IIIB-IV without regulatory impact) within program/disease area provide medical scientific input and/or develop study protocols and/or deliver MA studies as the Medical Lead in the Clinical Trial Team. Provide medical scientific input for the assigned program/disease area to co-develop with the appropriate functions an integrated Product Strategy (IPS), MA strategy and related MA plan as well as develop the medical affairs section of the clinical development plan. Provide medical scientific input into the development and dissemination of scientific data internally and externally, e.g. MSL training, Congress activities. Contribute to the review of scientific documents i.e. Scientific Review Committee, abstracts, posters, manuscripts. Provide guidance to CPOs related to their MA study program; review, approve and follow up on local MA studies. Key performance indicators: Achievement of annual targets for medical activities. Evidence generation and communication vs. quality / time target. Medical Affairs / Program budget execution vs. target. Compliance standards adherence. MD with specialty with board certification or equivalent, with 3 years of clinical research experience required or PhD with unique knowledge for successful clinical program development and execution, with 3 years of clinical research experience required. Medical Affairs and/or Market access experience. Medical and/or scientific expertise within disease area required. Experience in having launched a medication in a regional/global market. Demonstrated ability to establish strong scientific partnership with key investigators in assigned TA, academic institutions and scientific societies. Advanced medical/scientific writing and communication skills. Strong track record of collaboration in a matrix environment. Fluent English (Oral and Written). Skills: Agility. Clinical Development. Clinical Practices. Cross-Functional Collaboration. Data Analysis. Health Sciences. Healthcare Sector Understanding. Influencing Skills. Innovation. Integrated Evidence Generation. Medical Affairs. Medical Communication. Medical Education. Patient Care. Priority Disease Areas Expertise. Product Launches. Product Strategy. Real-World Evidence (RWE).

Direct, oversee and coordinate all activities, deliverables and resources within his/her respective group. Ensure that KPI's are met and work closely with Operations heads for resourcing, metrics and budgeting. Work seamlessly with partner groups. Lead, contribute to and implement initiatives to establish and maintain statistical programming as best in class in the industry. About the Role Key Responsibilities: As a functional leader of Advanced Quantitative Sciences, acting with an enterprise mindset, you will be fully involved in all aspects of Statistical Programming including the development of future strategies and processes. Contributing to the further development of the AQS organization with a focus on continuous improvement and quality by fostering statistical programming innovations, processes and solutions that ensure efficient implementation and knowledge sharing across Novartis. You will be required to drive productivity and efficiency measures to meet the strategic imperatives within AQS Early Development team, quality and productivity targets. Actively ensures that team's performance measures are being met or exceeded. May recruit, develop, manage, motivate, mentor, coach and appraise the performance of direct reports (DA Leads/Group Heads) to ensure high quality performance of the team and minimize turnover. Establish and maintain a high performing Organization. Mentor leadership talent and high performing associates. Responsible for performance management/feedback, professional development, and training. Establish and steer a business founded on disease area knowledge, innovation, collaboration, quality, and trust. In collaboration with P&O, develop, establish and maintain up-to-date strategies to attract and retain top talent across the globe maintaining a targeted recruitment strategy for key strategic positions, providing feedback as needed. Evaluate Statistical Programming requirements of computer systems and needs that relate to programming and reporting activities that foster use of emerging technologies in an innovative but compliant manner. Understands the needs and expectations of the different Health Authorities, ensures audit readiness and participates in Health Authority inspections. Monitors all assigned projects within Early Development, complying with Novartis, AQS and industry standards (e.g. CDISC) and processes. Identify the need for enhanced capability programs (R programming, Disease Area skills etc.) and support the establishment of technical, business, and soft skills for all Statistical Programming associates. Leads and supports global clinical and non-clinical projects and initiatives to drive functional excellence within AQS. This role offers hybrid working and will require 3 days per week or 12 days per month in our London Office. Your Experience: Proven leadership, collaboration and organizational skills with demonstrated ability to successfully manage simultaneous deliverables and meet deadlines. Must be fluent in English with a University Degree in life sciences, computer sciences, statistics or other relevant field. Excellent understanding of clinical trial methodology, GCP and medical terminology. Ideally 12 years' experience in Drug Development with at least 10 years in Statistical Programming. 7+ years' experience in a line management or equivalent leadership experience, such as matrix management. Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple simultaneous deliverables, ensuring deadlines are met. Experience in one of the TA: Immunology, Cardiovascular & Metabolic Diseases and Neuroscience is a must. 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 . 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. Please note that we are unable to apply for visa sponsorship at present. 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: Join our network . GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Functional Area: Research & Development Job Type: Full time Employment Type: Regular Shift Work: No

-Designs & develops safety surveillance strategy for products and approval. Responsible for the company's drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products' life cycle. Provides safety support to the clinical development teams. About the Role Global Program Safety Lead - Immunology Primary Location: London, United Kingdom Alternate Location(s): Barcelona or Madrid, Spain Working model: All locations have a hybrid working model (which requires 12 days per month in the office) Note: Novartis is not able to offer relocation support for this role. Please only apply if the location is accessible for you. About this role: Our Global Program Safety Lead excels as a scientific safety leader within the Immunology Medical Safety organization. Join us and you will make a significant impact on patients' lives and contribute to Novartis' overall success through robust safety evaluation expertise and medical innovation. Key Responsibilities: Safety Input and Team Participation: Provide expert safety input to the clinical development program for assigned projects/products and actively participate in the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT). Responsible for managing safety issues from the formation of the GPT through Life Cycle Management. Signal Detection and Safety Management: Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information, based on data from all relevant line functions, post-marketing data, and other sources. Documentation and Record Keeping: Ensure proper documentation, tracking, and record-keeping of medical safety activities for assigned compounds. Regulatory and Professional Inquiries: Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues. Safety Strategy Preparation: Lead the preparation of the safety strategy for health authority responses and collaborate with other project team members. Departmental and Functional Goals: Contribute to and often lead the development of departmental and functional/business unit goals and objectives. Marketing Samples Distribution: Manage the distribution of marketing samples, where applicable. Role Requirements: Medical Degree required 8+ years of experience in Big Pharma Skills: Clinical Research. Clinical Trials. Functional Teams. Leadership. Medical Strategy. Process Safety Management. Regulatory Compliance. Safety Science. Languages : Fluent English (both spoken and written) is mandatory. Additional languages are an advantage. 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.

-Understands complex and critical business problems from a variety of stakeholders and business functions, formulates integrated analytical approaches to mine data sources, employs statistical methods and machine learning algorithms to contribute to solving unmet medical needs, discover actionable insights, and automate processes for reducing effort and time for repeated use. To manage the definition, implementation, and adherence to the overall data lifecycle of enterprise data from data acquisition or creation through enrichment, consumption, retention, and retirement, enabling the availability of useful, clean, and accurate data throughout its useful lifecycle. High agility to be able to work across various business domains. Integrate business presentations, smart visualization tools, and contextual storytelling to translate findings back to business users with a clear impact. Independently set strategy, manage budget, ensuring appropriate staffing and coordinating projects within the area supervised. If managing a team: empowers the team and provides guidance and coaching, with limited guidance from more senior managers. About the Role Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together! The Role As an Associate Director Data Science in the Medical Affairs Advanced Quantitative Sciences group, you will be responsible for the discussion and implementation of data science methodologies applied to patient-level data (including various clinical, real-world, and biomarker data) across clinical development. You will combine your data science and AI skills and your scientific knowledge in biology or medicine to enrich drug development decisions in close collaboration with internal and external partners. This role offers hybrid working, requiring 3 days per week or 12 days per month in our London Office. Key Accountabilities: You will contribute to planning, execution, interpretation, validation, and communication of innovative exploratory analyses and algorithms, to facilitate internal decision making. You will provide technical expertise in data science and (predictive) machine learning/AI to identify opportunities for influencing internal decision making as well as discussions on white papers/regulatory policy. You will perform hands-on analysis of integrated data from clinical trials and the real world to generate fit-for-purpose evidence that is applied to decision making in drug development programs. Your Experience Ph.D. in data science, biostatistics, or other quantitative field (or equivalent). More than 6 years experience in clinical drug development with extensive exposure to clinical trials. Strong knowledge and understanding of statistical methods such as time to event analysis, machine learning, meta-analysis, mixed effect modeling, longitudinal modeling, Bayesian methods, variable selection methods (e.g., lasso, elastic net, random forest), design of clinical trials. Strong programming skills in R and Python. Demonstrated knowledge of data visualization, exploratory analysis, and predictive modeling. Excellent interpersonal and communication skills (verbal and writing). Ability to develop and deliver clear and concise presentations for both internal and external meetings in key decision-making situations. 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? 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. 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. GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Functional Area Data and Digital Job Type Full time Employment Type Regular Shift Work No

Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients' lives by leading innovation in nuclear medicine. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE). Job Description : The role of the Service Development and NHS Partnership Manager is to secure local access and uptake for AAA's radioligand therapy (RLT) portfolio within a defined territory, including by partnering with external customers to support development of critical service infrastructure. By working collaboratively with NHS and internal stakeholders, the role is a crucial function in helping to achieve equitable access, improved outcomes and quality of life for cancer patients eligible for RLT and to meet AAA's business objectives. Key responsibilities: • Develop strong working relationships with relevant regional NHSE, Cancer Alliances/ Operational Delivery Networks and ICS/ICB personnel to enable optimal funding and uptake of AAA's radioligand therapy portfolio as part of a defined locality access plan. • Develop AAA business and service development plan for each Cancer Alliance/Operational Delivery Network, tracking the execution and impact of activities in each account to ensure RLT is included in their strategic plans. • Build highly effective cross-functional relationships with AAA commercial team to help shape account plans through environmental insights and delivery of Market Access objectives, whilst proactively identifying opportunities for collaboration to deliver on brand objectives. • Proactively respond to the evolving NHS policy and commissioning landscape, including payers' needs, sharing insights across the AAA matrix organisation and supporting the development of radioligand therapy policy at national/regional/local level. • Gain multifaceted understanding of the RLT landscape, including access barriers, and develop innovative solutions and complex projects to overcome system obstacles. • Align AAA's RLT business objectives with NHS national and regional priorities, thereby securing agreement for service funding and delivery through engagement with NHS Trust key stakeholders. • Development of Market Access materials (toolkits, case studies based on best practices etc) to support the NHS in its set up, expansion and delivery of RLT services. • Provide compliant support to NHS customers to support them in the writing of business cases for set up and development of radioligand therapy services. • Execute joint or collaborative working projects with local NHS partners to improve patient outcomes and build trust via strategic relationships. • Engage with external agencies on targeted projects which will support AAA's business objectives and improve patient outcomes. • Attend NHS events across the UK where appropriate, sharing insights secured with AAA's matrix organisation. • Deliver Advanced Budgetary Notification within the ABPI code. • Support Government Affairs Director in national engagements and strategy, including with political and system stakeholders. • Always comply with all appropriate external regulations, ABPI Code of Practice and AAA principles and behavioural values. Diversity & Inclusion / EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. • Expert knowledge of the evolving NHS healthcare system, including structures, environmental landscape and policy environment around cancer. This includes, but is not limited to, decision-making, pathways, internal structural pressure within the system and local delivery challenges. • Considerable experience delivering successful service development and redesign projects, including joint/collaborative working projects, pathway mapping and business planning support within the NHS. • Proven ability to engage and influence policymaking/guidelines in national and regional decision-making bodies across the NHS and private market. • Strong organisational, planning and project management skills with ability to prioritise and efficiently maximise available time. • Team player experienced in collaborating cross-functionally across a matrix environment, acting respectfully yet courageously in communication with colleagues. Confident in challenging the status quo where appropriate. • Persistent, adaptable, resilient and solution focused. • Excellent written and verbal communication skills. • Preferred but not essential: Experience working with high-cost medicines or cancer alliances/ networks. = Novartis

Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With strong medicines pipeline our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly. We are now hiring a Director Medical Signatory to strategically lead, oversee and manage UK Medical Affairs Signatory Services and operations for Novartis Pharma UK and to act as the primary source of ABPI Code medical signatory advice for non-therapy aligned functions. Your responsibilities: Your responsibilities include, but are not limited to: Medical Leadership and Performance • Drive best in class launch preparedness and launch execution • Instil a data-informed and performance driven mindset in the organisation • Oversee the UK strategy, evolution of our operating model and understanding how UK is evolving in the life sciences sector, competitor benchmarking and analysis and defining how we operate as a business. • Govern matrix associates to deliver strong launch plans based on customer insights. Strategic and Business Mindset • Enterprise thinking in creating an operationally impactful and value adding signatory strategy, considering business imperatives, priorities, impact and risk, with focus on ultimately achieving compliance and strategy effectiveness • Responsible for driving excellence standards across franchises, identify opportunities, gaps and priorities, and contribute to best practice standards for an effective signatory service • Collaborates effectively across all parts of the business to define and influence signatory strategy, vision and goals Stakeholder and Vendor Management • Collaborates across TAs to develop a shared vision on the optimum way of working with our external vendor • Owns and optimizes vendor processes, contracts and relationship to create an operational service that delivers effectively and compliantly • Work collaboratively with ERC & Legal to lead Cross-border review & approval processes, lead the Grants & Donations Oversight Committee and associated budget • Reduce complexity of internal data systems by streamlining processes with simple solution-based approaches Leadership and Culture • People Development -develops talent and capability, builds effective and accountable teams, promotes engagement • Model for our culture, values & behaviours, consistently demonstrating the highest ethics and integrity based standards Diversity & Inclusion / EEO Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve. What you'll bring to the role: • Significant experience in medical affairs and ABPI code expert with experience in PMCPA code complaints. UK Registered Medical Practitioner or UK registered Pharmacist as signatory. • Strong leadership and influencing skills in a matrix organisation • Experience in external stakeholder and third-party management • Strong business acumen and strategic mindset • Leadership and people management experience • Excellent interpersonal skills, capable of coaching, mentoring and empowering associates You'll receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities. Why consider Novartis? 766 million. That's how many lives our products touched in 2021. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges. Imagine what you could do at Novartis! Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: We are Novartis. Join us and help reimagine medicine. = Novartis