Director, Global Clinical Development Operations Technology

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: October 8, 2021

Job Description:

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 www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

The Director, GCDO Technology will oversee the selection, implementation, development and adoption of technology within, and in support of, Global Clinical Development Operations (GCDO) and contribute significantly to technological innovation and roadmap for the broader benefit of Global Clinical Development Operations (GCDO) and Clinical Research and Development.  S/he is a forward-looking senior leader responsible for driving future technological innovation to meet the evolving needs of drug development. S/he will lead a team of professionals in technology 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 (DS&I) group within the GCDO structure and will be part of the DS&I Leadership Team.  S/he will fulfil the following essential functions and may also be assigned to other senior duties as assigned by the Head of GCDO Data Science and Informatics.

Essential Functions

• Serve as Overall Business Process Owner for the GCDO Technologies and develop and lead the execution of strategic plans and objectives for the GCDO Technologies, with respect to data and trial management; liaise with IT/IS group to ensure that the systems and capabilities are developed and implemented in alignment with GCDO business processes.
• Oversee the implementation and maintenance of the technology and CDF component of all standards and processes developed within DS&I and across GCDO, as appropriate.
• Oversee the selection, implementation, development and adoption of technology within DS&I and to support GCDO, liaising with relevant functions throughout the process.
• Collaborate 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 international.
• Provide 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 appropriate.
• Manage a team of professionals in the GCDO Technology group, 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 grow.
• Drive strong cross-functional relationships at senior leadership level (particularly with Clinical Data Management Operations, Clinical Operations, Medical Writing, Clinical Development, Biostatistics & Statistical Programming, Quality, Finance, IT/IS, and Medical Affairs) through frequent interactions and solid strategic thinking and communication skills; interact effectively with senior leadership when required.
• Serve 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 GCDO.
• Provides selection, management, leadership and oversight of Technology related CRO(s).
• Primary contact with GCDO Technology vendors (project management, business development, budget and contract development, and invoice approval). Establishes and assures adherence to budgets, schedule, work plans, and performance requirements.
• Participate in the generation and approval of GCDO Technology vendor related budgets and timelines.
• Partners with IT/IS group to ensure that the platform is developed and implemented in alignment with GCDO business processes.
• Serve as a member of the Digital Health Working Group, with a specific focus on applications in Clinical R&D.
• Partners with the Clinical Data Innovations (CDI) unit to ensures appropriate methods are used for reporting, metrics and analytics.
• Serves as a member on the Data Standards Committee.
• Coordinate closely with Clinical Data Management, Clinical Data Innovations, IT/IS, Quality, Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence.
• Resolve complex strategic issues in creative and effective ways, within DS&I but also across the broader Clinical Development space.
• Be active in industry organizations that promote the advancement of DS&I in general, or in technology innovation, application and implementation.
• Serve as a member of the DS&I Leadership team.
• Other duties as assigned.

Required Knowledge, Skills, and Abilities

• Thorough knowledge of various Clinical Development Operations Technologies and its role in the drug development process.
• Thorough understanding of the contributions of other functions critical to the execution of clinical trials.
• Experience of all stages of a clinical trial and vendor oversight.
• Thorough knowledge and understanding of the clinical trial technology space.
• Experience of managing and mentoring staff, preferably in the area of clinical technologies.
• Demonstrated knowledge of ICH/GCP guidelines as they relate to data management and technology.
• Experience with Clinical Operations metrics and operational oversight tools/dashboards required.
• Experience with Clinical Trial Management Systems and tools required.
• Experience developing and overseeing a Clinical Development Operations Technology roadmap required.
• Experience with eClinical Solutions elluminate platform is preferred.
• Experience with Medical Writing tools such as Litera and Structure Content Management preferred.
• Experience with Electronic Health Records and Wearables preferred.
• Experience working with big data preferred.
• Shown track record of oversight and modernizing GCDO Technologies and analytics in support of Clinical Development Operations preferred.
• Experience working with a geographically distributed team
• Ability 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.
• Solid leadership experience and the ability to hire and develop staff 
• Experience in managing first line managers
• Excellent communication/interaction skills and experience in a dynamic and growing organization.
• Must be a team player with strong interpersonal, organizational, project management and problem-solving abilities.
• Excellent written and verbal communication skills, with a high ability to communicate technology related topics, issues, options, and their impact to teams across GCDO.
• Experience representing GCDO related technologies in regulatory and/or internal inspections preferred
• Travel may be required

Required/Preferred Education and Licenses

• A minimum of a BA/BS, preferably in the scientific/healthcare and/or technology field. An advanced degree is preferred.
• A minimum of 15 years of experience in clinical related technology for the pharmaceutical/biotechnology industry
• Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data and studies.
• Working knowledge of FDA Guidance Documents: Computerized Systems Used in Clinical Trials, General Principles of Software Validation.
• Working knowledge of 21 C.F.R. Part 11.

Description of Physical Demands

• Occasional 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 Environment

• Work 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.

Keywords: Jazz Pharmaceuticals, Palo Alto , Director, Global Clinical Development Operations Technology, Other , Palo Alto, California