at Jazz Pharmaceuticals in Austin, Texas, United States
If you are a Jazz employee please apply via the Internal Career site
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.
The Associate Director, Clinical Operations 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. May be assigned to leading studies and study teams associated with a single molecule or may be assigned to studies and study teams associated with multiple molecules. Will be involved in the daily operations of Jazz Pharmaceuticals' 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. Will be responsible for the oversight and successful execution of Jazz Pharmaceuticals' clinical trials according to regulatory guidelines. Must facilitate effective internal and external relationships. Will be responsible for achievement of study goals and objectives on time, within budget, and with quality.
Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a clinical operations team. Conduct oversight of timelines, budgets, resources, CROs, and key deliverables
Actively contribute to the operational oversight and development of strategic direction for the following aspects of assigned studies:
Financial and recruitment modelling
Patient recruitment strategies
Provide leadership in vendor management and issue escalation.
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 Clinical Development, 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
Minimally 7-10 years of experience in the pharmaceutical or biotechnology industry; Haematology/Oncology experience required
Minimally 5 years of experience in a management capacity
Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations
Demonstrate experience of strategic thinking, clinical program and vendor oversight Demonstrated experience managing and mentoring clinical team members.
Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
International experience is highly preferred.
Must have extensive experience managing CROs, and other clinical study vendors.
Must have a working knowledge of data management, data review and analysis, and drug safety and Pharmacovigilance.
Ability to work on and solve complex problems.
Ability to prioritize and handle multiple tasks simultaneously.
Effective leadership skills and proven ability to foster team productivity and cohesiveness. Excellent communication/interaction skills... For full info follow application link.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, s ex, national origin, disability status, protected veteran status, or any characteristic protected by law.