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.
Brief Description:
Jazz Pharmaceuticals is seeking a clinical scientist to join the Clinical Development team in Oncology drug development. You will be responsible for supporting senior Clinical Development staff in formulating and executing the Global Development Plan (GDP) for the assigned molecule and indications. The focus of this role will be a solid tumour Oncology asset with significant potential across multiple indications. Responsibilities may include clinical leadership of projects supporting the development program strategy, supporting data management and data cleaning activities of Oncology studies, supporting the medical monitor in routine trial activities and oversight for Oncology studies, supporting regulatory submissions, and/or representing clinical development in multidisciplinary teams within Research and Development (R&D).
Essential Functions/Responsibilities
- Participate in the cross-functional team meetings and address study or other program-specific questions.
- Support execution and implementation of the Global Development Plan by providing strategic clinical science support for assigned studies and programs.
- Assist in reviewing and authoring study concept documents and clinical study protocols.
- Read and interpret scientific and medical literature for the use in clinical documents and to assist clinical team decision-making.
- Contribute to or prepare clinical sections of relevant regulatory filings and meeting packages (INDs, meeting requests, NDAs, etc.)
- Help to identify clinical investigators and coordinate 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 and ensure high standards of study conduct are met.
- Prepare clinical data and clinical program presentations.
- Review clinical study data; identify and evaluate study data trends, outliers, and protocol deviations; work with data management to issue and resolve queries to ensure data quality.
- Contribute to clinical study reports, including reviewing and interpreting safety and efficacy data.
- 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 communications (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 solid tumour oncology expertise preferred.
- 2+ years of experience working in a pharma/biotech company or postdoctoral or principal investigator experience within an academic or government setting.
- Willing to travel (variable, up to 20%)
Required/Preferred Education and Licenses
- PhD, MD, DO, PharmD, or other advanced scientific or clinical degree.
How to Apply: https://careers.jazzpharma.com/jobs/11294?lang=en-us