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Senior Director, Clinical Trial Supply Management (Remote US & EU)

Company: Disability Solutions
Location: Sacramento
Posted on: July 9, 2024

Job Description:

If you are a current 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 and follow @JazzPharma on Twitter. The Senior Director, Clinical Trial Supply Management (CTSM) leads the Clinical Trials Supply Management group to support the development and commercial portfolio to ensure that all clinical trials have timely and adequate clinical material supply for administration to subjects. Provides strategic and operational leadership of the CTSM team to deliver clinical material based on study needs. The CTSM group is involved in a clinical trial from the study inception and design to study closure.The CTSM group is responsible for assessment of clinical study design to determine demand forecasting, determination of appropriate CTM presentation to the clinical site(s) and subject, manage external vendors for labeling and packaging of CTM, inventory management at depots and sites, order and distribution management, and returns/destruction. Additionally the Sr Director implements processes and procedures as needed, and ensures group compliance to procedures for the production, packaging, labeling, and distribution of investigational products. Supervise/mentor members of the CTSM team. Reports to VP Global Pharmaceutical Development.Essential Functions

  • Overall strategic and operational leadership for supply of study drug for clinical trials, investigator initiated studies, and other studies as requested (e.g., nonclinical)
  • Manage CTSM Team to accommodate anticipated growth and to ensure continued professional growth across all levels
  • Provide oversight of clinical material supply and management activities to progress Jazz-sponsored clinical trials, Investigator sponsored trials, collaborations, and access programs.
  • Establish and maintain strong collaborative relationships with cross-functional stakeholders like R&D, clinical operations, regulatory, quality, legal, and finance.
  • Provide effective leadership and coaching to the team to ensure the development and growth of the business and its people
  • Provide strategic and creative solutions to overcome clinical supply challenges to achieve company goals and objectives
  • Develop timelines, budget and resource requirements for supply of clinical trial materials for prospective projects under consideration
  • Review of clinical designs and protocols and interpretation of protocols or study synopses to determine the requirements for CTM per study.
  • Oversee total demand calculations and translation of total demand into a supply demand (and demand forecast over time, as appropriate)
  • Extensive interaction among Quality/QP, Regulatory Affairs, Product Development, and Clinical Operations. Provides interface between the CMC and clinical teams and serves as CMC representative on Protocol Review Committee. Creates teams or working groups to manage CTM for development programs.
  • Provides general support to CMC teams (Product/Process Development) to facilitate support of clinical trials, which might include CMC approach to placebo development and blinding strategies
  • Generation of budgets and timelines for CTM, including coordination with Supply Chain where needed
  • Manage, or supervise management of, clinical packaging/distribution including contract negotiation, design of clinical supply plans, clinical labeling including label requirements and design, CTM packaging requirements and design, and development of the distribution and returns programs; import and export clinical trial material
  • Provides general support to Process/Product Development in the management of Jazz Pharmaceuticals' development programs and products
  • Implement and monitor improvement initiatives in line with continuous improvement philosophyMinimum Requirements
    • BS/BA degree, advance degree preferred
    • Extensive industry experience in CMC pharma development with an interface to clinical development/operations.
    • Knowledge/experience in drug development process (Phase I-IV) and cGMP, including broad exposure to multiple dosage forms and drug delivery technologies.
    • Strong interpersonal skills and ability to function in a dynamic team environment.
    • Vendor management experience with respect to manufacturing, clinical labeling/packaging/distribution/returns
    • Knowledge and experience in regulatory requirements for CTM and required CMC information for regulatory submissions to support clinical trials (IND, IMPD, CTA)
    • Experience with clinical labeling, packaging and distribution including controlled substances, cold chain, import/export
    • Experience with clinical blinding practices and clinical inventory control
    • Ability to handle multiple projects simultaneously
    • Ability to foster team productivity, cohesiveness, and collaboration
    • Excellent written and oral communication skills
    • Team player with strong interpersonal skills and ability to build effective working relationships throughout the organization.
    • To role model the company's core values and ensure that the organizational culture develops in support of them
    • Ability to inspire and promote a culture of change, innovation and self-improvement to all levels within the organization
    • Use of Microsoft Office including Word, Excel, PowerPoint, Visio and Project.
    • Flexibility to travel on company business up to 30% 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 ONLYJazz 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: $208,000.00 - $312,000.00Individual 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: .

Keywords: Disability Solutions, Sacramento , Senior Director, Clinical Trial Supply Management (Remote US & EU), Executive , Sacramento, California

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