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.
The successful candidate will work cross-functionally to help generate, analyze and integrate data from preclinical models, clinical trials and external collaborations. The goal is to provide fundamental insights into the heterogeneity of human diseases and the design of precision medicine hypotheses that can be tested in clinical trials and enable the discovery and development of CNS therapeutics. The expected output is the identification of key translational evidence providing the 'reason-to-believe' in new indication opportunities and in support of high-quality, scientifically-based product development decisions by key stakeholders.
This is a high-profile role requiring an individual with outstanding communication and leadership skills. Vital to this role is the ability to build strong relationships with stakeholders in our Early Development, Clinical Development, Biostatistics, Regulatory and other functions within Jazz and to work effectively with external academic and industry collaborators. The individual should have demonstrated the ability to author scientific sections of regulatory documents.
- Serves as a scientific leader within the Translational Science Department and as a TS representative of Jazz neuroscience activities with internal and external stakeholders.
- Critical review and evaluation of published literature to develop biomarker hypotheses and design/oversight of experimental plans for hypothesis testing to support project objectives.
- Integration of preclinical and clinical data with regulatory and commercial strategy to develop detailed project plans in support of TS neuroscience program objectives.
- Authors, reviews and approves scientific, regulatory and strategic documents including (but not limited to) study protocols and reports, scientific manuscripts, regulatory documents, integrated development plans, and other corporate documents.
- Embodies and models Jazz Pharmaceuticals core values (integrity, collaboration, passion, pursuit of excellence and innovation.
Required Knowledge, Skills, and Abilities
- Basic understanding of nervous system anatomy, neurological circuitry, ion channel and neurotransmitter function and mechanisms of CNS drug action is required.
- Experience in neurology drug discovery and development is desired, for example experience with in vivo models of CNS disease, brain penetration, receptor occupancy, electrophysiology, neuro-imaging and/or CSF sampling.
- Experience with human clinical experimental medicine techniques including (but not limited to) evoked potentials, transcranial stimulation, pharmaco-EEG, functional-MRI, digital wearable technologies, and/or polysomnography is highly desired.
- An understanding of the development and execution of biomarker and precision medicine strategies as part of clinical trials, with contributions to the design of clinical study protocols and supporting regulatory, clinical operations and data management documents.
- Strong leadership and collaboration skills to work and lead in a matrix environment which includes research, clinical development and commercial / marketing functions
- Exceptional organizational skills with attention to detail; demonstrated project management skills.
- Outstanding verbal and written communication skills; ability to write technical reports and to present complex data.
- Experienced in analyzing datasets including genomic and transcriptomic, imaging and clinical experimental medicine measurements for the purpose of developing precision medicine hypothesis.
- Experience in contributing to the writing of key regulatory documents (e.g. IND, IB, marketing applications).
Required/Preferred Education and Licenses
- PhD, MD or MD/PhD degree in a relevant scientific field (e.g. neurosciences, bioinformatics, biomedical engineering).
- A minimum of 10 years post-MD/PhD experience in an academic, clinical and/or industry setting.
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.