Director, Global Clinical Development Operations Technology
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: October 8, 2021
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
- 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
- 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
- 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
- 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
- Resolve complex strategic issues in creative and effective
ways, within DS&I but also across the broader Clinical
- 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
- Thorough knowledge and understanding of the clinical trial
- 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
- Experience developing and overseeing a Clinical Development
Operations Technology roadmap required.
- Experience with eClinical Solutions elluminate platform is
- Experience with Medical Writing tools such as Litera and
Structure Content Management preferred.
- Experience with Electronic Health Records and Wearables
- Experience working with big data preferred.
- Shown track record of oversight and modernizing GCDO
Technologies and analytics in support of Clinical Development
- Experience working with a geographically distributed team
- Ability to work on and solve complex problems.
- Ability to prioritize and handle multiple tasks
- Effective leadership skills and proven ability to foster team
productivity and cohesiveness.
- Solid leadership experience and the ability to hire and develop
- 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
- 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
- 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
- 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
Occasional public contact requiring appropriate business
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
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