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Associate Director, Clinical Scientist Neuroscience

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Company :
Jazz Pharma

Location :
Philadelphia, Pennsylvania

Expiry Date :
Wed, 30 Jun 2021 23:59:59 GMT

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Description :
OVERVIEW:

Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases – often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.

We are looking for the best and brightest talent to join our team. If youre 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 youll explore our career openings and get to know Jazz Pharmaceuticals.

RESPONSIBILITIES:

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 Development Plan (GDP) 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

* Participates in the cross-functional team meetings and addresses study or other program-specific questions
* Develops the Global Development plan with the senior clinical development staff for assigned molecule(s)/indication(s) and/or other programs
* Implements Global Development Plan by providing strategic clinical science support for assigned studies and programs
* Assist in reviewing and authoring Study Concept Document 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 clinicalportionsof 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.
* 2+ years of clinical/scientific research experience required, with neuroscience expertise preferred.
* 2+ years of experience working in a pharma/biotech company or postdoctoral or principle investigator experience within an academic or government setting.
* Travel opportunities (up to 5-20% of time).

REQUIRED/PREFERRED EDUCATION AND LICENSES

* PhD, MD, DO, PharmD, or other advanced scientific or clinical degrees

_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._