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 will be responsible for implementation, execution and oversight of clinical trials in coordination with cross-functional team members to base on the strategic vision for molecules in the R&D pipeline. S/He may be assigned to leading studies associated with a single molecule or may be assigned to studies associated with multiple molecules. S/He 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. 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.
- 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:
- Operational feasibility
- Financial and recruitment modeling
- Implementation planning
- Protocol development
- Vendor selection
- Patient recruitment strategies
- Financial forecasting
- 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; neuroscience and/or Hematology/Oncology experience preferred
- 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 and experience in a dynamic and growing organization.
- Travel Required
Required/Preferred Education and Licenses
- Bachelor's degree required, although track record of continuing education is preferred;
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
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.