If you are a current Jazz employee please apply via the Internal Career site.
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 visitwww.jazzpharmaceuticals.comfor more information.
The Senior Manager, Clinical Outsourcing will lead and manage the clinical trial outsourcing for Jazz Pharmaceuticals’ clinical development programs across clinical study phases pre- and post-authorization. Under the direction of leadership in Clinical Outsourcing s/he is responsible for the vendor evaluation and selection, contract negotiation and maintenance, and vendor relationship management processes in support of Jazz’ clinical studies.
Essential Responsibilities:
- Collaborates with cross-functional (Legal, Finance, FP&A, Clinical Operations, etc.) departments relating to developing and managing vendor contracts and budgets and managing vendor performance.
- Collaborates with vendors to proactively manage risk, resolve issues, address questions, and optimize ways of working as outsourcing partners
- Leads the vendor evaluation and selection process in accordance with clinical outsourcing and clinical sub-category strategies, partnering with internal Jazz stakeholders and cross-functional business partners
- Generates RFPs, RFIs and contract templates in support of the clinical outsourcing process and in compliance with standard operating procedures and policies.
- Negotiates clinical vendor contracts and budgets, including MSAs and statement of work (SOWs) for CROs and other clinical category vendors.
- Acts as an issue escalation point for study teams managing and escalating vendor performance issues, as required and in accordance with vendor governance charters and established issue escalation pathways
- Represents Clinical Outsourcing to cross-functional teams/clinical trial working groups, coaching R&D on current processes and policies as it relates to Clinical Outsourcing and the clinical contracts process, as required
- Submits and manages purchase requisitions and contracts through the approval process in Jazz’s S2P system
- May lead or participate in departmental initiatives/projects in support of Jazz R&D and/or Global Procurement
- May develop and lead clinical sub-category strategy(s) and key vendor relationship(s)
- May lead or support vendor governance activities, as required
- May supervise and contribute to the training and professional development of staff
Required Knowledge, Skills, and Abilities
- Minimum 5 years of clinical outsourcing experience
- Experience in Neurology and/or Oncology preferred
- Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
- Must have a comprehensive understanding of the drug development process
- Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety
- Experience collaborating cross-functionally to develop RFPs, RFIs, and study budget/contract templates
- Proven track record negotiating complex clinical services contracts and budgets with both U.S. and international vendors
- In-depth knowledge of compliance and legal issues related to the conduct of clinical trials phase 1 - 3. Experience with post authorization phase 4 preferred.
- Experience managing CROs, central laboratories, and other clinical study vendor relationships
- Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues
- Demonstrated strength in time and project management with the ability to prioritize and handle multiple competing tasks simultaneously and under pressure
- Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees.
- Some limited travel may be required
Required/Preferred Education and Licenses
- Bachelor’s degree required; Master’s degree (MS, MBA), 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: $141,600.00 - $212,400.00
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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