$100K — $150K *
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 Associate Director, Clinical Operations – Global Medical Affairs (GMA) will be responsible for implementation, execution and oversight of clinical trials in coordination with cross-functional team members based on the strategic vision for molecules in the R&D pipeline for our Global Medical Affairs studies. S/He may be assigned to studies and study teams associated with multiple molecules and therapeutic areas. S/He will be involved in the daily operations of Jazz Pharmaceuticals’ GMA clinical studies and oversee the strategy and execution. This person will lead a team of clinical operations professionals and will be expected to provide vision, leadership, and mentoring to their assigned team. S/he must have an expert and comprehensive understanding of ICH/GCP requirements, principles, concepts, industry practices, and standards. S/he must have an expert and comprehensive understanding of the GMA space, as S/He will be responsible for the oversight and successful execution of Jazz Pharmaceuticals’ clinical trials according to regulatory guidelines. S/he must facilitate effective internal and external relationships. S/he will be responsible for achievement of study goals and objectives on time, within budget, and with quality.
Provide leadership in vendor management and issue escalation. Work closely with GMA Clinical Scientists to develop Medical Affairs led studies including the development of synopses, protocols and plans.
Build, manage, and maintain high performing clinical teams
Contribute to planning to ensure optimized clinical operational strategy for assigned projects.
Provide technical expertise for the development of clinical documents (protocol, informed consent form, CRF, monitoring plans, regulatory submission documents, clinical study report, investigator brochures, etc.).
Coordinate closely with Global Medical Affairs, Biostatistics, Data Management, Drug Safety, Legal, Finance, Project Management, Medical Writing, Clinical Trial Supplies Management and Regulatory to ensure operational excellence.
Be responsible for and manage clinical research activity of Clinical Trial Managers, Clinical Trial Specialists and applicable vendors.
Prepare/assess clinical research budgets and timelines.
Analyze and develop action plans to address issues with clinical studies, investigational sites, and CROs.
Required Knowledge, Skills, and Abilities
Required/Preferred Education and Licenses
Description of Physical Demands
Description of Work Environment
Valid through: 4/26/2021
$150K — $200K + tbd