Senior Manager, Clinical Trial Supply Management
Category: Manufacturing | Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4006
Same Job Available In Three Locations
Palo Alto, California, United States
Philadelphia, Pennsylvania, United States
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 Senior Manager, Clinical Trial Supply Management will work as a member of the Jazz Pharmaceuticals’ team, assisting in the development of new products and product line extensions by managing investigational products in support of the clinical development pipeline and other clinical and non-clinical studies. The core responsibilities include on-time delivery of study drug to patients/subjects and management of the clinical supply chain (packaging, labeling, distribution, inventory management, returns, and destruction of IMP/CTM). Key interactions are with Clinical Operations, Clinical Development, Pharmaceutical Development, Quality, and Regulatory, and with external vendors (packaging, IRT). The position reports to the Senior Director, Clinical Trial Supply Management.
- Ensure on time delivery of clinical supply to depots and sites in accordance with each clinical protocol and plan
- Work with cross-functional team to define clinical supply plan for each study; participate in relevant team meetings providing clinical supply status reports and support
- Review clinical protocols for study supply requirements
- Create label text in compliance with regulations, and manage translations and country –specific requirements.
- Contribute to the design of study drug packaging in accordance with needs of the study
- Manage vendors to perform the labeling, packaging, and distribution (global) of investigational product
- Assist the development of IRT (IXRS) supply and return strategy, and participate in User Acceptance Testing where needed
- Develop requirements/specifications for clinical study drug and other drug supply as required (GLP, non-GLP non-clinical), including packaged product specifications, product shipping and storage specifications
- Contribute to study specific pharmacy manuals and supply related training/instructional materials (e.g. IM and SIV slides, dosing cards, accountability forms)
- Coordinate with Supply Chain for use of commercial products in a clinical environment
- Stay current on all Jazz SOP’s related to CTM/IMP distribution and follow procedures for release of IMP to clinical site(s)
- Contribute to CTSM budget and forecasting; track invoices to contracts
- Provide to Regulatory Affairs any applicable information or sections of IND/IMPD/CTA/etc. submissions
- Bachelors Degree and a six to eight years professional experience, or equivalent experience, in pharmaceutical/biotech industry.
- Experience in clinical trial supplies required; supply chain/distribution logistics/import export/customs experience a plus
- Knowledge of regulatory requirements for IMP.
- External vendor management experience required
- Excellent written and oral communication skills.
- Ability to work independently with minimal oversight
- Strong interpersonal skills and ability to function in a dynamic team environment.
- Strong computer skills, with proficiency in spreadsheet, presentation and word processing software.
- 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.