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 manage clinical trials in coordination with a clinical operations team. S/He will be involved in the daily operations of Jazz Pharmaceuticals’ clinical programs through vendors. There is potential that this person in time 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. Under the direction of the Clinical Operations Lead for a given Therapeutic Area, s/he is responsible for clinical trial management through CROs, oversight and successful execution of Jazz Pharmaceuticals’ clinical trials according to regulatory guidelines. S/he must facilitate effective internal and external relationships. S/he is responsible for achievement of project goals and objectives on time and on budget.
- Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team.
- Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials
- Provide direction and leadership in CRO and vendor selection and management.
- Knowledge of regulatory start up process and planning in support of study start up
- Building, managing, and maintaining high performing clinical teams
- Contribute to strategic planning to ensure optimized clinical development plans for assigned projects.
- Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
- Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.
- Be responsible for and manage clinical research activity of Clinical Trial Managers, Clinical Trial Specialists and contract CRAs.
- Prepare clinical research budgets and timelines
- Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs
Required Knowledge, Skills, and Abilities
- Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations
- Demonstrate experience of study start up 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, central laboratories, 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;
- Proven experience in the pharmaceutical or biotechnology industry
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.