Jazz Pharmaceuticals is seeking a clinical development physician to lead a team in Sleep- CNS drug development. This person will be responsible for leading a team that oversees the development of multinational clinical studies, the interpretation of clinical trials data, clinical interactions with multidisciplinary groups across the company including R&D, commercial, regulatory and business development, and with external stake-holders including regulatory agencies and thought leaders. The lead may oversee a collaborations with partner companies to oversee the joint development of multiple products. In addition, the lead will contribute to the overall Jazz strategy in CNS and contribute to due diligence activities that will lead to additional assets being brought into the Therapeutic Area. The position will require a deep understanding of neuroscience and relavnt clinical experience in the CNS therapeutic area
- Lead Sleep-CNS Clinical Development Product Team and Lead cross-functional strategy for development of CNS products
- Develop and implement strategic clinical plans in alignment with goals for the Sleep/CNS TA .
- Work within a matrix Research and Development ogranization to drive the clinical and scientific strategy for new therapies in CNS
- Devise executive strategy to develop and implement clinical studies for investigational medicines and new indications for approved medicines
- Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programs
- Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjuction with project team members, regulatory affairs and senior management
- Provide clinical/scientific input during the development, execution and completion of clinical trials
- Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, etc) and review sections from other functional areas
- Serve as lead medical representative with regulatory agencies
- Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
- Lead the development and implementation of communication/education programs designed to effectively communicate the therapeutic area to key opinion leaders, investigators and physicians
- Lead clinical advisory board meetings to obtain strategic input into clinical program development
- Serve as clinical (and medical) resource for clinical issues raised by internal and external collaborators, investigators, consultants and business development and investor contacts
- Partner with corporate development on the identification of external assets to build and strengthen the therapeutic area
- Provide clinical expertise and strategic input on new product concepts, long-range strategic plans and licensing opportunities
- Provide leadership to the multidisciplary team and and may manage other members of the clinical development team
Required Knowledge, Skills, and Abilities
- Seven plus years of pharmaceutical development experience in CNS or adjacent therapeutic areas
- Demonstrated scientific and therapeutic experience in CNS
- Experience in preparation of regulatory submissions (INDs and NDAs) to US and European regulatory agencies. Lead preparation of clinical portions of relevant regulatory documents.
- Excellent written and verbal communication skills and proven ability to work in an international collaborative environment
- Ability to effectively lead cross functional teams and successfully leverage internal and external partnerships
- Excellent organizational and time management skills, ability to lead and manage multiple complex projects
- Demonstration of Jazz values in previous employment
- Demonstrated leadership ability
- A scientific track record demonstrated by publication record in peer reviewed journals
- Travel required (up to 10%-20% of the time)
- Medical degree, MD with specialized training in Neurology, Psychiatry and/or Sleep Medicine. ; U.S. Board Certification/Eligibility preferred
- Collaborative and flexible in personal interactions at all levels of the company
- Ability to work proactively and effectively, with exceptional creative problem solving skills
- Proven strategic planning and communication skills across multiple disciplines
- Demonstrated ability to work with senior management and provide input toward the setting and execution of corporate and departmental objectives
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.