Director, Clinical Science

Company: Jazz Pharma
Location: Philadelphia
Posted on: January 15, 2021

Job Description:

Overview: 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. Responsibilities: Jazz Pharmaceuticals is seeking a clinical scientist to join a development team in hematology/oncology drug development. You will be responsible for supporting senior clinical development staff in the development of the Global Development Plan (GDP) and various deliverables for executing the assigned molecule(s)/indication(s).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 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
• Write protocol summaries, process documents, investigator brochures, etc. in collaboration with cross-functional groups
• Collaborate on reviewing safety narratives and other safety-related guidelines and documentation.
• 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.)
• Communicate relevant medical inquiries through collaboration with clinical development, clinical operations, data management, and safety
• Participate and develop communication strategies for existing and concluded studies through KOL interactions, advisory boards, scientific and industry conferences and meetings, and publicationsRequired Knowledge, Skills, and Abilities
  • Outstanding written and oral communicati on skills
  • Proven ability to work independently and as part of a multidisciplinary team
  • Collaborative and flexible in personal interactions
  • Passi onate about improving patient care
  • 2+ years of corporate, government, or academic pharmaceutical development experience preferred
  • 3+ years of experience in scientific research in hematology/oncology is requiredRequired/Preferred Education and Licenses
    • Bachelor s Degree required (life sciences preferred)
    • PhD, MD, DO, PharmD, or other advanced scientific or clinical degrees are preferredDescription of Physical Demands
      • Mobility within office environment (between offices, conference rooms, and buildings)
      • Sitting or standing for extended periods of time
      • Constantly using a computer, printer, telephone, and other office machineryDescription of Work Environment
        • Office environment with limited exposure to excessive noise, dust, fumes, vibrations and extreme temperature changes
        • Responsibilities may require a work schedule that includes working outside of "normal" work hours, in order to meet business demands
        • Occasional professional conferences and meetings that require appropriate business attire 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. Associated topics: biopharma, biopharmaceutical, drug development, food, immunology, metabolism, microbiological, nutritionist, protein, vaccine

Keywords: Jazz Pharma, Philadelphia , Director, Clinical Science, Healthcare , Philadelphia, Pennsylvania