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Executive Director, Late-Stage Oncology Clinical Operations

Jazz Pharmaceuticals

Posted on: 01 Apr 2024

Job Location: Palo Alto, US

Job Description:

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. Brief Description: The Executive Director, Late Stage Oncology Clinical Operations will lead a team of clinical operations professionals charged with the execution and delivery of our Oncology Phase 1 -3 pipeline. S/he must have extensive knowledge and experience in solid tumor clinical development from planning through approvals. This includes strategic operational planning, project cost estimations, global experience and a working knowledge of regional challenges, experience with the use of companion diagnostics (cDX) in clinical research, understanding of the competitive landscape and experience working with industry KOLs. HER2 positive clinical research experience is preferred. S/he must also have an expert and comprehensive understanding of ICH/GCP requirements, principles, concepts, industry practices, and standards. 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. This person is also responsible for staff development and financial management. S/he will be an acting member of the Global Clinical Development Operations (GCDO) leadership team. Essential Functions Direct all operational aspects of the Jazz late stage oncology clinical development pipeline Assure the accuracy and appropriateness of clinical research budgets and timelines. Support development teams in scenario planning/costing Influence development team thinking to enable high quality, operationally feasible clinical trial protocols and plans Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs Provide direction and mentorship to staff including setting goals that are aligned with both Corporate and project goals. Building, managing, and maintaining high performing clinical teams. Provide input and leadership into CRO and vendor selection and management. Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct. Partner with Clinical Development, Data Sciences, Clinical Trial Supply Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence. Required Knowledge, Skills, and Abilities Minimum of fifteen years related experience in the pharmaceutical or biotechnology industry with at least 10 years experience in the oncology space Demonstrated excellent verbal, written, and interpersonal communication skills in relating to colleagues across various levels and both internal and external to Jazz Demonstrated in-depth knowledge of clinical research functions and ICH GCPs Demonstrated excellent understanding of regulatory and legal issues related to drug development, and specifically the conduct of clinical trials Demonstrated business and financial acumen Demonstrated strong negotiation and conflict resolution skills Demonstrated strong clinical operations expertise Deep understanding of metrics and KPIs and their use in clinical trials and portfolio management Demonstrated deep knowledge of the clinical trial technology and innovation ecosystem and strategies Required/Preferred Education and Licenses A bachelor s degree in a related field is required MBA or equivalent advanced degree preferred 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 $256,000-$384,000. 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:

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