Senior Manager, Clinical Scientist - Neuroscience

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

Brief Summary

Jazz Pharmaceuticals is seeking a Clinical Scientist to join a Clinical Development team in Neuroscience drug development. You will be responsible for supporting senior clinical development staff in the development of the Global Clinical Development Plan and for executing various deliverables for the assigned molecule(s)/indication(s). Responsibilities include clinical leadership of development programs, medical monitoring of clinical trials (if MD), contributing to neuroscience clinical development strategy, supporting regulatory submissions, and representing clinical development in multidisciplinary teams within R&D.

Essential Functions/Responsibilities

• Participates in the cross-functional team meetings and addresses study or other program-specific questions
• Develops the Global Clinical Development plan with the senior clinical development staff for assigned molecule(s)/indication(s) and/or other programs
• Implements Global Clinical Development Plan by providing strategic clinical science support for assigned studies and programs
• Assist in reviewing and authoring clinical study outline and clinical study protocols.
• Read and interpret scientific and medical literature for the use in clinical documents and to assist clinical team decision making
• Prepare clinical portions of all relevant regulatory filings and meeting packages (INDs, meeting requests, NDAs, etc.)
• Help identify clinical investigators and coordinate their activities for the conduct of clinical trials and advisory board meetings
• Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, nonclinical) to facilitate the execution of clinical trials
• Prepare clinical data and clinical program presentations
• Review clinical study data; identify and evaluate study data trends, outliers, and protocol deviations
• Review, interpret, and approve safety and efficacy data in clinical study reports.
• Write protocol summaries, process documents, investigator brochures, etc. in collaboration with cross-functional groups
• Provide input on clinical presentation slides for internal/external meetings and communication (e.g., investigator meetings, pre-study site selection visits, site training, study newsletters, communication to sites, etc.)
• Participate and develop communication strategies for existing and concluded studies through KOL interactions, advisory boards, scientific and industry conferences and meetings, and publications

Required Knowledge, Skills, and Abilities

• Excellent oral and written communication skills.
• Proven ability to work independently and as part of a multidisciplinary team
• Collaborative and flexible in personal interactions with high emotional intelligence.
• 1+ years of clinical/scientific research experience in neuroscience (epilepsy a plus/ preferred).
• 1+ years of experience working in a pharma/biotech company or postdoctoral or principle investigator experience within an academic or government setting.
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