Clinical Study Planning & Technical Services
The Planning and Technical Services Department based in the UK is part of a global group managed from our headquarters in the US. Our global group contains a diverse group of specialists, each supporting their respective project teams with study planning and placement, managing timelines and performance measurement and reporting
Another of our key roles is working with technical service providers in the areas of Electronic Trial Operations (ETO), central laboratories and imaging. Our technical specialists proactively ensure that quality standards are met by sharing best practise and in-process oversight of provider activities.
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Clinical Quality Assurance
Amgen operates in a regulated environment and the Clinical Quality Assurance (CQA) Department evaluates the quality and compliance of all aspects of Amgen’s clinical development processes against regulations and guidelines.
We highlight risks and facilitate the sharing of best practices. Our CQA personnel visit investigator sites, Contract Research Organisations (CROs), vendors and Amgen affiliates. We also assess Amgen’s internal processes and facilitate Good Clinical Practice (GCP) regulatory inspections. We share our knowledge of regulations, guidelines, Standard Operating Procedures (SOPs) and current inspection issues to help improve processes across a variety of teams and work streams within International Research and Development.
Facilities
The Facilities Management Department is responsible for the buildings that Amgen occupies in the UK and various support services. Our role is to provide a safe and efficient working environment for all employees, and one that enables the business to function effectively. We employ many disciplines to achieve this, including property and space management, building and engineering services maintenance, health & safety, and contract management of service providers such as catering and security. The Facilities Team work in conjunction with both the International Research & Development and UK/Ireland (Commercial) business groups.
Global Study Management
Our Study Management Departments are part of global teams committed to bringing new therapies to patients in a variety of disease areas, including oncology, renal failure, osteoporosis and inflammatory diseases. We are responsible for planning and overseeing the cross-functional execution of global and regional clinical studies (phase 2-5) to enable initial licensing and subsequent lifecycle management of new medicines.
Our activities include: core membership of the Global Development Team, leadership of cross-functional Study teams, contribution to the writing and review of study documentation including protocols, initiation of study feasibility, selection of clinical investigators, management of study budgets, timelines and partners, data collection and analysis, as well as ensuring high quality and compliance with GCP (Good Clinical Practice) and Standard Operating Procedures (SOPs).
The Early Development Therapeutic Area provides an experienced management and monitoring resource for Amgen’s early phase studies. We are responsible for selecting and building effective working relationships with specialist Clinical Research Centres where such studies are conducted. Where possible, we work with these centres to initiate, develop and maintain relationships with Key Opinion Leaders (KOLs) who will be important for the later stages of development.
Early Development is a focal point for all regional study management activities, providing expert scientific and strategic advice on Phase 0 and Phase 1 opportunities.
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Human Resources
The Human Resources (HR) professionals at Amgen serve as business advisors for our functional areas and as specialists offering expertise in areas including Benefits & Compensation, Staffing, HR Operations, Security, Diversity and Training & Development.
We are encouraged to seek out new challenges to broaden our experience, such as moving between generalist and specialist roles. Whether through staffing, upgrading performance management or designing and implementing leadership development programs, we help to shape the company’s functions and work environment. We are seen as having an integral role in helping Amgen achieve it's business objectives whilst working with individual staff members to meet their career goals.
Information Systems
The International Development IS Department delivers information systems services to all clients within International Research and Development.
We partner extensively with our peers in International IS, UK IS Customer Services, and our Thousand Oaks Development IS peer groups based in California, to improve our clients’ productivity through business process support and improvement. This is often accomplished via delivery and support of information systems solutions which address the management, logistical and communication needs of Amgen's drug development engine.
Within our group we have multi-dimensional, IS professionals with backgrounds in software development, project management, software and process validation, and technical support. We continue to expand our team with individuals having pharmaceutical industry experience or relevant credentials from other industries with similar IS needs.
International Biomedical Data Sciences
This function is comprised of a number of sub-functions:
The Biostatistics Department provides statistical guidance and strategic direction in the design of interventional and non-interventional clinical trials, existing data projects, product development programmes and value evidence generation packages. We undertake the statistical analysis and reporting of these clinical research activities, contribute to the interpretation and the publication results in the medical literature and conference presentations. Our global function consists of statisticians based in the US, Canada and the UK.
The Epidemiology Department undertakes the design, analysis and reporting of epidemiological studies and provides epidemiological advice and support to observational research activities within R&D functions and corporate affairs. We make use of large medical care databases held in-house and supported by a team of programmers. In addition, we work more generally to promote the understanding and effective use of observational research to inform and complement our drug development programs, clinical trials and value evidence generation programs. Our global function includes epidemiologists, analysts and statistical programmers based in the US and the UK.
The Statistical Programming Department develops innovative software to analyze and report on clinical study data in support of scientific research and regulatory submissions. Our aim is to use leading edge technology including SAS®, S-PLUS® and the internally developed SDF system to generate validated statistical outputs and analysis datasets (CDISC compliant SDTM and ADaM) to the highest quality in compliance with internal SOPs and external regulatory guidelines. Partnering with Biostatistics, CDM, Epidemiology and Clinical, GSP (Global Statistical Programming) has statistical programmers, developers and Infrastructure Programmers based in the US and the UK.
The Clinical Data Management Department is a global function that collects and manages the data generated during the conduct of Amgen’s global clinical trials, from phase 0 through to phase 4. Our aim is to provide a clean and complete dataset, on time and with quality, to our Biostatistics and Statistical Programming Departments for analysis and reporting. We are split into two main groups: CDM Systems & the Therapeutic Area Teams. CDM Systems are responsible for developing the data capture tools and databases; whilst the Therapeutic Area Teams are responsible for the management of the data and are members of the Global Clinical Study Teams.
The Operations department is a global function that partners with Biostatistics, Epidemiology, Statistical Programming and CDM to support various project management, process improvement, performance management and regulatory compliance efforts. Our global function is based in the US and UK.
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Legal
The UK Legal Team within the International Law Group consists of a team of Paralegals reporting to our swiss-based Legal Counsel. The Paralegals have specific geographic and functional responsibilities with the primary focus of providing legal support to Global Study Management, Contracting, Regulatory Affairs and Compliance. The Team works for internal clients, providing advice and training on a variety of legal and regulatory issues. The team is also in charge of creating and updating clinical trial contract templates. Responsibilities further extend to contractual negotiations and the construction, tracking and maintenance of all the required clinical trial contracts as well as the review and approval of Informed Consent Forms.
Medical Department
R&D Financial Planning & Analysis
The Financial Planning & Analysis (FP&A) Department provides support to the whole of International Research & Development. It is part of a larger global FP&A department, headed up from the US headquarters.
We support over 40 departments across more than 15 countries, which means dealing with multiple currencies, global working and high complexity. Our key responsibilities and activities are: Budget & Latest Estimate (LE) forecasting, monthly reporting on expenses and Full-Time Equivalents (FTEs), adhoc financial analysis, cost modeling and scenario planning.
We are also the initial finance point of contact for queries on processes, and have involvement in many key cross-functional International and global projects.
R&D Project Management and Strategic Operations
The International R&D Project Management & Strategic Operations group forms part of the Global Department, and is focused on managing projects effectively and integrating strategy and operations to deliver the best R&D pipeline and bring products to patients more quickly. Our vision is achieved through portfolio prioritisation, lifecycle management, capacity management and efficient use of resources, cross-functional alignment, risk management, training and compliance. R&D Project Management & Strategic Operations incorporates three distinct functions: Planning, Portfolio and Capacity Management (PPCM); R&D Standards & R&D Training.
Regulatory Affairs
The Regulatory Affairs Department provides a crucial link between the company, its products and the regulatory authorities. Within the company, our regulatory professionals must negotiate effectively across a broad spectrum of disciplines, from manufacturing and clinical, to marketing and legal. Externally, we have responsibility for communicating and arbitrating with both the European Medicines Agency (EMEA), national European agencies such as the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and other agencies in the rapidly expanding International territories. The Regulatory Affairs Department plays a pivotal role in presenting the scientific evidence to the regulatory authorities that the quality, safety and efficacy testing of the product are appropriate for the proposed prescribing information. This role begins right at the drug discovery stage and continues for as long as the drug is on the market.
A sub-function of our department, the Document Records Centre (DRC) is responsible for the administration, storage, retention and eventual archiving of the majority of Amgen's essential regulatory & clinical study documentation in support of submissions to regulatory authorities.
Safety
The Amgen Global Safety (AGS) Department contributes to clinical development and commercial operations in ensuring regulatory compliance. Similar to other Development functions, it has an integrated International presence, with staff placed in the UK and most of Amgen's local Country Offices across Europe.
For products under development, we contribute to protocol design (defining the safety data to be collected), evaluate safety data, prepare regulatory reports (for serious adverse reactions) and contribute to the safety sections of investigator brochures during Phases 1-3. We also make a significant contribution to annual reports and product license applications.
Operationally driven, once a product has been marketed we analyse and report on spontaneous events, maintain data sheets and review and distribute Periodic Safety Update Reports (PSURs). We have an input into Phase 4 study design, and appraising and summarising concomitant safety data. Furthermore, we compile information in order to reply to regulatory safety questions and maintain awareness of competitor product safety profiles. In addition, we collaborate with the US headquarters team, ensuring a strong International input into the development and implementation of safety plans.
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Supplier Performance Management
The Supplier Performance Management (SPM) Department is a key participant in the start-up and execution of our clinical studies. We support clinical study activities across all regions through the evaluation, selection and management of service providers. We also manage clinical study related contracts, including those with Clinical Research Organisations (CROs), Central & Specialist Laboratories and other technical service providers. In addition we provide budgets for patient fees paid to investigators, hospitals and consultants across Europe, ensuring they are in line with industry benchmarks for fair market value.
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