Jazz Pharmaceuticals
Global Study Leader
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About Jazz Pharmaceuticals
Jazz Pharmaceuticals is a global biopharma company dedicated to innovating and transforming the lives of patients and their families through the development of life-changing medicines for serious diseases. Our portfolio includes leading therapies for sleep disorders and epilepsy, as well as a growing range of cancer treatments. We are committed to a patient-focused and science-driven approach that powers our research and development in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland, with global operations, including research and development laboratories, manufacturing facilities, and employees worldwide.
For more information, visit www.jazzpharmaceuticals.com.
Essential Functions/Responsibilities
- In partnership with the study team and internal and external service providers, provides oversight to ensure study delivery and operational excellence.
- Delegate tasks to study team members as appropriate.
- Lead the implementation, execution, and management of global Phase I–IV clinical trials.
- Lead, facilitate, and delegate trial-related meetings, ensuring alignment with cross-functional teams.
- Act as a primary point of escalation for cross-functional stakeholders for timely issue resolution and alignment.
- Participate in program-level discussions (FMT, GPT), providing clear and timely updates to senior management (as needed).
- Develop and execute clinical trial strategies in collaboration with cross-functional teams during the trial lifecycle, including tracking and reporting trial progress, risks, and mitigation strategies to senior leadership.
- Hold overall accountability for the Trial Master File (TMF). Acts as an SME for Clinical Operations related sections.
- Lead the development and review of trial-specific plans and essential clinical trial documents.
- Review and approve key trial documents, including protocols, informed consent forms, monitoring plans, and Clinical Study Reports (CSRs), in line with Standard Operating Procedures (SOPs).
- Actively contribute to the operational oversight and strategic direction of assigned studies, including feasibility assessments, planning, vendor selection, patient recruitment strategies, and financial forecasting.
- Contribute to the planning and conduct of Investigator Meetings, including driving meeting preparation, presenting trial materials, and supporting effective delivery of key messages.
- Identify, assess, and proactively manage risk and contingencies to safeguard timelines, quality, and compliance.
- Develop, manage, and track trial timelines and budgets, in line with projected spend. Estimate, track, and critically analyze vendor financial spend on trials.
- Accountable for the oversight and management of external service providers and vendors to ensure quality, compliance, and performance.
- Oversee trial tracking activities and ensure accurate, timely updates within trial management systems.
- Accountable for the final approval and oversight of trial documentation archiving in compliance with regulatory and company requirements.
- Serve as trial lead and SME during audits and inspections.
- Coordinate Investigational Medicinal Product (IMP) shipment authorization with regulatory and clinical supplies functions.
- Assist and support the data query process.
- Perform monitoring visit report review (as required).
- Lead and participate in Clinical Operations / Global Clinical Development Operations (GCDO) initiatives (as assigned).
- Serve as a Clinical Operations SME in the design and review of processes.
- Ensure trial activities are conducted according to GCP and relevant SOPs and in accordance with the agreed timelines and trial protocol.
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Leadership / People Management Responsibilities
- Mentor and coach Global Study Managers (GSMs), Clinical Research Associates (CRAs), and Global Study Associates (GSAs) to support professional development.
- Lead Clinical Trial Working Groups (CTWGs).
- Provide leadership in resolving complex trial issues and escalating risks appropriately.
- Manage and maintain high-performing clinical teams.
Required Knowledge, Skills, and Abilities
- 7+ years of clinical research experience, with proven global trial management and portfolio-level oversight with a minimum of 3 years in clinical operations leadership roles.
- Excellent organizational skills, time-management, and attention to detail.
- Excellent written and verbal communication skills and stakeholder management abilities.
- Ability to work both independently and collaboratively in a fast-paced environment.
- Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
- Experience with and strong knowledge of clinical trial electronic systems (e.g., TMF, Clinical Trial Management System (CTMS), etc.).
- Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements.
- Strong knowledge of the regulatory start-up process and planning in support of Study Start-Up (SSU).
- Proven track record of effectively managing in a cross-functional environment.
- Excellent project management skills with a proven track record of managing global, multi-center clinical trials.
- Strong leadership and governance experience; ability to influence at senior levels.
- 10% to 20% domestic and international travel.
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Required/Preferred Education and Licenses
- Bachelor’s degree, preferably in life sciences, healthcare, or a related field, or equivalent experience.
- Advanced degree preferred.
Equal Opportunity Employer
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.
Compensation for US Based Candidates
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices. For this role, the full and complete base pay range is: $140,000.00 - $210,000.00.
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.
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