Vice President, Global Clinical Development Lead, Sleep - Palo Alto, C
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.
Position ProfileThis 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
- 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
- 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.