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Senior Manager, Clinical Outsourcing (Remote)

Company

Jazz Pharmaceuticals

Address Mississauga, Ontario, Canada
Employment type FULL_TIME
Salary
Category Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-08-27
Posted at 9 months ago
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
Under the direction of the Associate Director, the Senior Manager, Strategic Outsourcing will lead and manage the clinical trial outsourcing, vendor selection and contract negotiation, management, and reporting process for Jazz Pharmaceuticals’ clinical development programs.
Essential Functions
  • May lead or roll out departmental initiatives/projects in support of Jazz R&D.
  • Collaborates with cross-functional (Legal, Finance, FP&A, Clinical Operations, Data Management) departments on activities relating to vendors and business partners
  • Takes a leadership role in coaching R&D on current processes and policies as it relates to Clinical Outsourcing
  • Leads the evaluation, selection and negotiation and contracting process with vendors and sites in conjunction with functional teams
  • Utilizes insight from data analytics and tracking tools to support vendor performance management and cost-savings initiatives
  • Represents Strategic Outsourcing to cross-functional teams, providing training on outsourcing and contracts process as required
  • Oversees the development and negotiation of CDAs, clinical site budgets and clinical trial agreements with investigative sites
  • May lead or support vendor governance activities, as required
  • Works with vendors for to proactively manage risk, resolve issues and address questions
  • Partners with internal Jazz stakeholders to develop, deliver and maintain clinical outsourcing strategies and relationships.
  • May manage/supervise and contribute to the training and professional development of staff
  • Generates RFPs, RFIs and contract templates in support of the clinical outsourcing process
  • Creates and provides budget forecasts and cost-modeling for clinical trials, as needed
  • Leads and manages the negotiation of clinical development contracts, including MSAs and work orders for CROs and other clinical category vendors such as eCOA, IRT and central laboratories.
Required Knowledge, Skills, And Abilities
  • Must have a comprehensive understanding of the drug development process
  • Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and compliance and legal issues related to the conduct of clinical trials
  • Must have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sites
  • Some limited travel may be required
  • Proven track record negotiating contracts and budgets with international vendors and clinical sites
  • Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety
  • Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
  • Strong time and project management skills with the ability to prioritize and handle multiple tasks simultaneously
  • Extensive experience collaborating cross-functionally to develop RFPs, RFIs, and study budget/contract templates
  • Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees.
Required/Preferred Education And Licenses
  • Bachelor’s degree with minimum five years of clinical outsourcing experience
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 anticipated base pay range is $121,600-$159,600. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.
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