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 Functions
- 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
- 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
Description of Physical Demands
- 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
- 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.