Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Clinical development physician or scientist who will served as the Clinical Lead on 1 or more Neuroscience clinical studies. This individual will lead the protocol development and is responsible for the interpretation of clinical trials data including interactions with multidisciplinary groups across the R and D organization, and with external stakeholders including regulatory agencies and thought leaders. In addition, the lead will contribute to due diligence activities that will lead to additional assets to expand the pipeline.Essential Functions
Required Knowledge, Skills, and Abilities
- Lead Neuroscience Clinical Development Product Team and Lead cross-functional strategy for development of Neuroscience products
- Develop and implement strategic clinical plans in alignment with goals for the Neuroscience TA.
- Work within a matrix Research and Development organization to drive the clinical and scientific strategy for new therapies in Neuroscience
- 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 conjunction 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 (if an M.D.)
- Serve as medical monitor (if an M.D.)
- 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
- Provide clinical expertise and input on new product concepts, long-range strategic plans and licensing opportunities
- Provide leadership to the multidisciplinary team and may manage other members of the clinical development team
- Substantial pharmaceutical development or relevant academic experience in Neuroscience or adjacent therapeutic areas
- Demonstrated scientific and therapeutic experience in Neuroscience
- 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
- 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
Description of Physical Demands
- 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
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
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.