Director, Clinical Data Innovation

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter. Brief Description: The Director, Clinical Data Innovation (CDI) will oversee the selection, implementation, development and adoption of technology, and will contribute significantly to technological innovation for the broader benefit of Global Clinical Development Operations (GCDO) and Clinical Research and Development. S/he is a forward-looking senior leader that will work alongside the leaders within Data Science and Informatics (DS&I), GCDO and R&D to drive future technological innovation to meet the evolving needs of drug development. S/he will lead a team of professionals in Clinical Programming and related disciplines, and will be expected to provide vision, leadership, and mentoring to that team. S/he will facilitate effective internal cross-functional and external vendor and industry relationships. S/he will be expected to contribute extensively to the development and growth of the Data Science and Informatics group within the GCDO structure. S/he will fulfil the following essential functions and may also be assigned to other senior duties as assigned by the Head of Data Science and Informatics.Essential FunctionsServe as Business Process Owner for the Jazz Clinical Data Factory (CDF) - a data depository system, and develop and lead the execution of strategic plans and objectives for the Jazz CDF, with respect to data review and trial management; liaise with IT groups to ensure that the platform is developed and implemented in alignment with GCDO business processesOversee the implementation and maintenance of the technology and CDF component of all standards and processes developed within DS&I and across GCDO, as appropriateOversee the selection, implementation, development and adoption of technology within DS&I and to support GCDO, liaising with relevant functions throughout the processCollaborate with DS&I and GCDO leadership to ensure that all aspects of the group''s technology applications are consistent with current industry practices and meet all pertinent regulatory requirements, both domestic and internationalServe as a full member of the Digital Health Working Group, with a specific focus on applications in Clinical R&DProvide senior level input to the identification, evaluation and selection of new technology of potential benefit in Jazz clinical trials, and contribute to the implementation, development and adoption of such technology as appropriateManage a team of professionals in Clinical Programming and related disciplines, and provide vision, motivation, leadership, and mentoring to that team. Plan, hire and adapt resources as needed to ensure key goals are met on time. Provide the team with reliable guidance to succeed and growDrive strong cross-functional relationships at senior leadership level (particularly with Clinical Data Management Operations, Clinical Operations, Clinical Development, Biostatistics & Statistical Programming, Quality, Finance, IT, and Medical Affairs) through frequent interactions and solid strategic thinking and communication skills; interact effectively with senior leadership when requiredServe as the primary strategic interface with technology vendors, including but not limited to membership of Steering / Governance committees established with such vendors. Maintain and expand current professional knowledge in technology as applied to clinical trialsResolve complex strategic issues in creative and effective ways, within DS&I but also across the broader Clinical Development spaceBe active in industry organizations that promote the advancement of DS&I in general, or in technology application and implementationServe as a member of the DS&I Leadership teamRequired Knowledge, Skills, and Abilities Thorough knowledge of data management and its role in the drug development processThorough understanding of the contributions of other functions critical to the execution of clinical trials, and their interactions with data managementExperience of all stages of a clinical trial and vendor oversightThorough knowledge and understanding of the clinical trial technology spaceExperience of managing and mentoring staff, preferably in the area of clinical technologyDemonstrated knowledge of ICH/GCP guidelines as they relate to data management and technologyExperience working with a geographically distributed teamAbility to work on and solve complex problems.Ability to prioritize and handle multiple tasks simultaneously.Effective leadership skills and proven ability to foster team productivity and cohesiveness.Excellent communication/interaction skills and experience in a dynamic and growing organization.Required/Preferred Education and LicensesBA/BS, preferably in the scientific/healthcare field At least 10 years of experience in data management for the pharmaceutical/biotechnology industrySolid leadership experience and the ability to hire and develop staff Experience in managing first line managersDescription of Physical DemandsOccasional mobility within office environment.Routinely sitting for extended periods of time.Constantly operating a computer, printer, telephone and other similar office machinery.Description of Work EnvironmentWork indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.Frequent computer use at workstation.May move from one work location to another occasionally.Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.Occasional public contact requiring appropriate business apparel.Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Created: 2021-11-29