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Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
Job DescriptionEssential Functions/Responsibilities
In partnership with the study team and internal and external service providers, provides oversight to ensure study delivery and ensure operational excellence.
Delegate tasks to study team members as appropriate.
Lead 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 contributes 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 final approval and oversight of trial documentation archiving in compliance with regulatory and company requirements.
Serves 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 data query process.
Perform monitoring visit report review (as required).
Lead and participate in Clinical Operations / Global Clinical Development Operations (GCDO) initiatives (as assigned).
Serves 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.
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 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
Required/Preferred Education and Licenses
Bachelor’s degree, preferably in life sciences, healthcare, or a related field, or equivalent experience.
Advanced degree preferred.
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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.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is:
$140,000.00 - $210,000.00Individual 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
Skills Required
- 7+ years of clinical research experience
- At least 3 years in clinical operations leadership roles
- Proven global trial management and portfolio-level oversight experience
- Excellent organizational, time-management, and attention-to-detail skills
- Excellent written and verbal communication skills
- Stakeholder management abilities
- Ability to work independently and collaboratively in a fast-paced environment
- Proficiency in Microsoft Office, including Word, Excel, Outlook, and PowerPoint
- Experience with and strong knowledge of clinical trial electronic systems, including TMF and CTMS
- Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements
- Strong knowledge of regulatory startup processes and Study Start-Up planning
- Proven ability to manage cross-functional environments
- Excellent project management skills and experience managing global, multicenter clinical trials
- Strong leadership and governance experience with ability to influence senior stakeholders
- Bachelor's degree, preferably in life sciences, healthcare, or a related field, or equivalent experience
- Advanced degree
Jazz Pharmaceuticals, Inc Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Jazz Pharmaceuticals, Inc and has not been reviewed or approved by Jazz Pharmaceuticals, Inc.
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Fair & Transparent Compensation — Fair & Transparent Compensation: Pay is considered competitive to strong versus biopharma peers, reinforced by market-competitive ranges in public postings. Company materials emphasize a robust total-rewards mix of base, bonus, and equity.
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Parental & Family Support — Parental & Family Support: Global paid child-bonding leave for all parents and paid caregiver leave are explicitly offered. Additional paid time elements like bereavement and a Global Volunteer Day expand family and life-event support.
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Wellbeing & Lifestyle Benefits — Wellbeing & Lifestyle Benefits: A market-leading mental-health program provides extensive counseling and coaching access via Lyra. A Wellbeing Reimbursement Account and wellness resources broaden everyday lifestyle support.
Jazz Pharmaceuticals, Inc Insights
What We Do
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 focused on developing life-changing medicines for people with serious diseases—often with limited or no options—so they can live their lives more fully. By transforming biopharmaceutical discoveries into novel medicines, we are working to give people around the world the opportunity to redefine what’s possible – to make the “small wins” big again. Founded in 2003 and headquartered in Dublin, Ireland, Jazz Pharmaceuticals has a significant corporate presence in Palo Alto, CA, Philadelphia, PA and Oxford, England, with manufacturing facilities in Ireland and Italy. We maintain a highly collaborative culture where employees focus on how they can be successful and accomplish positive results by exemplifying the company’s core values: integrity, collaboration, passion, innovation and the pursuit of excellence. Together, we are more than 3,100 experts, analysts, specialists, advocates, scientists and professionals all with diverse backgrounds and perspectives. Working together, we are proud to support patients, innovate and bring new medicines to market. For more information, please see our website at www.jazzpharma.com and follow us on Twitter at @JazzPharma. For information on fraudulent schemes involving our company name and recruitment, please visit https://bit.ly/2J1EjMA. For guidelines on engaging with Jazz on social media, please visit https://bit.ly/2OaMOuq.
