Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.
The Associate Director/Director, Clinical Trial Supply Management will work as an integral member of Jazz Pharmaceuticals' team, supporting the research and development of new products. The Associate Director/Director, Clinical Trial Supply Management will manage clinical trial supplies in support of the development pipeline and other clinical and non-clinical studies. Is responsible for translation of clinical study design to IMP requirements, including demand forecasting, design of CTM presentation to the clinical sites and subject (e.g., blinding strategy, packaging and labeling design), manage external vendors for all aspects of clinical supply chain (from bulk procurement to drug returns and destruction). May also provide general CMC support for projects and products. The core responsibilities include management of supply/demand planning, labeling, packaging, distribution, returns, and destruction; inventory control; supply management via IRT. Key interactions will be with Jazz Clinical Development/Operations, CMC team, Quality, and Regulatory, and with external vendors. Provides key input to internal IMP policies and procedures. Acts as mentor to, and may supervise, members of the CTSM team. The position reports to the Senior Director, Clinical Trial Supply Management.
- Responsibility for on-time supply of study drug for clinical trials
- Utilizes expertise to evaluate clinical designs/protocols and determine the strategy for the design and management of the clinical trial material
- Create specifications for CTM and other drug supply as required (GLP, non-GLP non-clinical), including label copy, packaged product specifications, product shipping and storage specifications
- Develop cost estimates/budgets and timelines for CTM to support governance review programs, and manages programs to approved budget.
- Develops CTSM goals for programs under their responsibility
- Manage the execution of CTM labeling and packaging; may also manage manufacture of material
- Manage entire clinical supply chain including vendor contract negotiation, design of clinical supply plans, clinical labeling requirements/design, packaging requirements/design, development of the distribution and returns programs; procurement, import, export of investigational product.
- Stays apprised of regulatory landscape and quality requirements with respect to investigational products.
- Represents PDMS on CTWG. Provides interface between the CMC and CTWG teams. Key interactions are with Clinical Operations, Quality/QP, Regulatory Affairs, PDMS.
- Provides general support to CMC teams in support of clinical trials, which might include CMC approach to placebo development, blinding strategies
- Prepare, in conjunction with Regulatory Affairs, appropriate sections of the Chemistry, Manufacturing, and Controls sections of IND/IMPD/etc. submissions
- Coordinate with Supply Chain for use of commercial products in a clinical environment
- BS/BA degree, advanced degree a plus
- 8-10 years industry experience in clinical supply chain or closely related field (e.g., CMC, quality). Job level commensurate with skills and experience.
- Knowledge/experience in overall drug development process and cGMP
- Team player with strong interpersonal and communication skills with ability to build effective working relationships throughout the organization and with external vendors
- Vendor management experience with respect to clinical labeling/packaging/distribution/returns
- Knowledge and experience in regulatory requirements for CTM/IMP and required information for regulatory submissions to support clinical trials (IND, IMPD, CTA)
- Experience with clinical labeling requirements, packaging, and distribution, including cold chain, import/export (controlled drug experience a plus)
- Experience with clinical blinding practices, clinical inventory control, interactive response technologies
- Ability to handle multiple projects simultaneously
- Use of Microsoft Office including Word, Excel, PowerPoint, Visio and Project.
- Flexibility to travel on company business as required.
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.