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Director, Clinical Data Management

Company: Jazz Pharma
Location: Palo Alto
Posted on: November 22, 2020

Job Description:

Job DescriptionOverview: Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs. We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals. Responsibilities: The Director, Clinical Data Management, is a forward-looking senior leader responsible for driving future innovation to meet the evolving needs of drug development. S/he will lead a team of Clinical Data Management and Clinical Programming professionals (Associate Directors, Sr. Managers (CDM/CP), Managers (CDM/CP)). S/he may be Therapeutic Area (TA) Head and/or Technical Area Business Owner (eg. process, innovation, etc.). S/he is expected to use broad expertise and/or unique knowledge and skills to contribute to development of corporate objectives and to achieve goals by enabling and supporting the CDM function in the production of high-quality data to inform execute leadership decisions. S/he will be a primary thought leader by developing and communicating a compelling vision, sense of purpose and clear operational roadmap for the CDM function within the Clinical Development Operations (CDO) structure. S/he will facilitate effective internal cross-functional, external vendor and industry relationships. S/he will fulfil the following functions: Essential Functions Leadership * Design and drive overall organizational vision and strategic direction across the TA portfolio: project planning including: scope, timeline, budget, staffing requirements, data standards and governance (in collaboration with CDO Senior Leaders when necessary) * Design and drive overall organizational vision and strategic direction across key innovations to advance CDM capabilities, by monitoring external innovations and driving adoption internally and externally, to meet the growing needs of the portfolio: project planning including: accelerated drug development, optimized risk-based quality management, enhanced analytic capabilities (in collaboration with CDO Senior Leaders when necessary) * Foster and promote the long-term development of the CDM group, work closely with the RDLT, CDO Senior Leaders, and CDM managers to improve cross-functional operational excellence * Identify resource needs to support TA portfolio to minimize costs and maximize utilization/realization to ensure key goals are met on time. Develop, forecast, and manage departmental budget * Build strongly aligned teams that apply their diverse skills and perspectives to strive for success by providing a shared vision, coaching, mentoring and promoting an inclusive environment * Ensure progress and execution of efforts to standardize work practices and develop standard operating procedures in conformance with GCP, GCDMP, and ICH guidelines, and that meet regulatory submission requirements, and CDISC standards to drive operational excellence, cross-functional efficiencies, and shorter study start up timelines * Serve as a key member on data standards governance (if required by Data Standards Lead) * Drive strong cross-functional relationships at senior leadership level (particularly with CDO, Clinical Development, Biostatistics, Statistical Programming & Medical Writing, Quality, Regulatory, Finance, IT, and Medical Affairs) through frequent interactions and solid strategic thinking and communication skills * Resolve complex strategic issues in creative and effective ways, within the CDM space but also across the broader Clinical Development space * Serve as the primary interface with vendors and internal Jazz senior leaders in the area of TA oversight and strategy, serve as key member on the vendor/CRO joint operating committee and internal TA team Management * Collaborate with Talent Acquisition to plan recruiting strategy to attract exceptional candidates with a strong emphasis on both technical and cultural fit * Supervise the CDM group, CDM leaders, and other CDM staff (e.g. FSP, contractors) as needed * Collaborate with CDM and R&D senior leadership to develop department goals and ensure connection to personnel goals of CDM staff in support of the corporate objectives * Provide career development and performance management of individual employees * Manage escalated conflict resolution through open communication, teamwork, diplomacy, and mediation * Maintain current professional knowledSDL2017

Keywords: Jazz Pharma, Palo Alto , Director, Clinical Data Management, Executive , Palo Alto, California

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