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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.