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Director, Clinical Data Management

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Company :
Jazz Pharma

Location :
Philadelphia, Pennsylvania

Expiry Date :
Thu, 15 Apr 2021 23:59:59 GMT

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Description :
OVERVIEW:

Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases – often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.

We are looking for the best and brightest talent to join our team. If youre 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 youll 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 knowledge of regulatory requirements and industry best practices in relevant areas of CDM, technology advances, and quality assurance
* Participate actively in industry organizations that promote the advancement of CDM in general, or in the therapeutic area to which s/he is assigned
* Participate in corporate development of methods, policies, techniques and evaluation criteria for projects, programs, and people
* Oversee therapeutic area portfolio management for operational consistency and data excellence
* Provide CDM or operational drug development input to the selection of Contract Research Organizations (CROs) and other data vendors
* Participate in due diligence team in evaluating potential in-licensing assets or external trials such as cooperative/collaborative studies.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

* Thorough knowledge of data management and its role in the drug development process
* Thorough understanding of the contributions of other functions critical to the execution of clinical trials, and their interactions with data management
* Experience of all stages of a clinical trial and vendor oversight
* Thorough knowledge and understanding of the therapeutic area to which s/he will be assigned
* Experience of managing and mentoring Data Managers
* Solid understanding of different data management systems and technologies
* Demonstrated knowledge of ICH/GCP guidelines as they relate to data management
* Thorough understanding of CDISC CDASH and SDTM standards
* Extensive experience managing CROs and other data vendors
* 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
* Excellent communication/interaction skills and experience in a dynamic and growing organization

REQUIRED/PREFERRED EDUCATION AND LICENSES

* BA/BS, preferably in the scientific/healthcare field
* At least 10 years of experience in data management for the pharmaceutical/biotechnology industry
* Solid leadership experience and the ability to hire and develop staff
* Experience in managing first line managers

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._