Manager, Advanced Analytics and AI - GCDO Business & Technology Capabilities (Re

The Manager, Advanced Analytics and AI - GCDO Business & Technology Capabilities demonstrates broad knowledge of the Clinical Development process, the technologies, systems, and applications that support this, as well as hands-on development of advanced analytics, machine learning, or AI-related programs. The role is responsible for the design, development, production, delivery, and support of advanced analytics and Artificial Intelligence/Machine Learning (AI/ML) programs primarily supporting Global Clinical Development Operations as well as other functions in R&D. The Manager, Advanced Analytics and AI - GCDO Business & Technology Capabilities collaborates with a diverse set of stakeholders and leaders across various functions who utilize supporting technology solutions. Strong communications skills, a solution and problem solving-first mindset, broad technical proficiency in Statistics, Machine Learning and algorithm development, clinical digital systems/analytics, and experience with clinical trial operations and processes is required. Essential Functions/Responsibilities Facilitates the design, development, production and delivery of Global Clinical Development Operations (GCDO) Advanced Analytics and AI/ML projects in order to achieve operational excellence, optimize data quality and realize efficiencies wherever possible Represents their department and collaborates with Digital Enterprise Capabilities (DEC), Advanced Analytics and AI Center of Excellence (AAAI CoE), Clinical Operations, Outsourcing, Medical Writing, Clinical Data Operations, Early Development and Trial Solutions, and other functions within R&D regarding the implementation and management of AI/ML solutions used by GCDO and R&D Accountable for the delivery of digital systems, Advanced Analytics/Reporting, AI/ML solutions on behalf of GCDO, working alongside DEC, AAAI CoE counterparts and other departments within GCDO Acts as an expert advisor regarding advanced analytics/reporting and AI/ML solutions to ensure optimal trial design and performance, aid continuous improvement and innovation Independently identifies new technologies/solutions that may be relevant to GCDO, assists with building business cases, ROI, design and development, delivery, etc Establishes, maintains, reviews and manages the Advanced Analytics and AI/ML solutions on behalf of GCDO Collaborates with other functional areas/departments and key stakeholders to maximize the utilization of the Advanced Analytics and AI/ML solutions (e.g. designing novel algorithms, creating advanced visualization tools and applications, reports, ensuring best use of all existing solutions, proposing and developing potential new technologies, and optimizing and expanding use of subscription software and data) Collaborates with partner vendors and solution providers, as needed, in relation to system knowledge sharing and utilization which may or may not include contract and subscription review for accuracy and accountability Maintains a sound familiarity with Jazz’s systems and related processes, with a primary focus in R&D Identifies improvement opportunities related to Advanced Analytics and AI/ML solutions and assists with developing enhancement plans and roadmaps Independently leads cross-functional projects and initiatives representing GCDO Business & Technology Capabilities Ability to act as an expert advisor and subject matter expert on behalf of all of GCDO Business & Technology, which requires deep knowledge and understanding of the functions within the department Required Knowledge, Skills, and Abilities Experience developing Advanced Analytics and AI/ML solutions for the pharmaceutical industry, with an emphasis on R&D specifically IT-literate and passionate/experienced towards new technology and digital systems (e.g. Microsoft-based applications, CTMS, eTMF, EDC, IRT, Operational Data Analytics, Clinical Data Analytics, Veeva Vault suite, Planisware, and clinically focused subscription databases) An experienced R&D technologist who is well versed in the field of clinical development operations, combined with excellent technical and programming experience, project management, training & mentoring capabilities Experience personally designing and programming AI/ML solutions, clinical technologies, and dashboards/reports/analytics. Including the development of business requirements, user stories, algorithm development, application coding and development, validation documentation, and user training or system support/materials (e.g. SOPs, WIs, User Manuals) Previous experience with analytics platforms and programming capabilities such as SQL, SAS, R, Python, etc Has a sound working knowledge of clinical operations, clinical processes, medical terminology, global CROs, clinical technologies, and vendor management Excellent interpersonal, verbal and written communication skills Ability to work independently and take initiative Flexible approach with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload, with attention to detail and excellent organizational skills Ability to handle highly complex projects/task Ability to work effectively in a matrix environment and to demonstrate, and foster, teamwork within the group, as well as across the organization Ability to travel as needed for the position Excellent ability to think and work globally and to be culturally aware Required/Preferred Education and Licenses A minimum of a BA/BS, preferably in the computer science, statistics, physics, scientific/healthcare and/or technology field required. Strongly preferred Masters in Statistics, Data Science, or Advanced Analytics with a focus on Machine Learning, Artificial Intelligence, or Process Automation A minimum of 5 years of experience in clinical related technology for the pharmaceutical/biotechnology industry required. Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data and studies required. Working knowledge of FDA Guidance Documents: Computerized Systems Used in Clinical Trials, General Principles of Software Validation required. Working knowledge of 21 C.F.R. Part 11 required.

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