Job Information
Jazz Pharmaceuticals, Inc. Vice President, Global Clinical Development Lead, Sleep in Palo Alto, California
Vice President, Global Clinical Development Lead, Sleep
Clinical Development
Palo Alto,
California
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This role will develop and oversee the development projects within the Sleep Medicine Therapeutic Area including Life-Cycle Management (LCM), providing strategic and technical strategic support and ensuring that projects are making progress consistent with strategic objectives and project plans.
Essential Job FunctionsJob Responsibilities:
Ensure leadership of the Sleep Medicine Development Teams in the Research & Development Matrix structure
Work with the Development Teams, Global Molecule Teams and Sleep-Franchise Team Leads to shape the drug development strategies in alignment with the Therapeutic Area strategy and priorities
Oversee the translation of the Development and LCM strategies into operational plans
Prepare for Development Strategies and Operational Plan decision making by the appropriate governance bodies, in alignment with Jazz governance principles.
Ensure overall projects stay on track and in line with strategic objectives by supervising development projects within a therapeutic area with shared accountability with the assigned Project Manager for overall project execution
Present project progress, key issues, analysis and recommendations to the Development Review Committee (DRC). Decide what is to be presented to Development Committee in agreement with the Development Committee Secretary.
Work with Project managers (PMs), Global Molecule Lead (GML) and/or Sleep TAH/Sleep-Franchise Team leads to escalate issues and to resolve issues in alignment with R&D Governance process
Provide technical advice and leadership into projects, informed by expertise in the therapeutic area as well as utilizing internal and external technical experts
Serve as member of Therapeutic Area Core team
Advise Sleep TAH, Sleep-Franchise Team Leads and Head of R&D Operations on project strategy and resource planning
Provide Sleep TAH, Sleep-Franchise Team Leads and Head of R&D Operations with insight into the development project process and important risks
Assist PMs in developing project meeting agenda and action items
Work with functional heads to ensure all project team/sub-teams have appropriate representation and leadership as needed, including personal leadership and, when appropriate, delegated development representation
Provide input and info to Sleep TAH, Sleep-Franchise Team Leads on upcoming R&D governance meetings as appropriate
Lead Clinical Development Function in Sleep Medicine, including supervisory responsibility of Clinical Development staff, departmental administrative responsibilities for budget and R&D governance responsibilities wherever VP, Clinical Development roles are required.
Support Corporate Development technical assessment of new opportunities
Required Qualifications
Ten or more years of experience leading or overseeing sleep or CNS disorders-related pharmaceutical development projects to include managing such projects across multiple functional areas.
Demonstrated ability to successfully execute development plans
Significant experience with NDA/BLA preparation and submissions
Advanced Doctoral Degree required
Experience with projects relating to Sleep Medicine or CNS
Required Competencies
Demonstrated ability to lead and influence experienced professionals
Ability to lead in a fast changing environment
Broad knowledge and exposure across all R&D functions
Deep understanding of pharmaceutical development
Strategic thinker
Strong execution skills
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, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.