Summary of Key Responsibilities:
• Work actively with Clinical Operation/Study team to help create forecast for each study and program, including enrollment rate.
• Support country logistics for shipping and importation.
• Subject matter expert for clinical trial supply during regulatory inspections.
• Help develop an Inventory strategy per program, study and region.
• Monitor regularly drug expiry, and the appropriate inventory re-supply.
• Design packaging requirements
• Monitoring of enrollment, drop-out rates and actual supply needs. Ensure continuous re-assessment of Project needs.
• Responsible for the sourcing of comparators and matching placebo as needed.
• Drive label creation and approvals process, including translations for all countries.
• Support a vendor management process.
• Develop and support the governance process with CMOs.
• Work with vendors to generate inventory reports, and review regularly budget and spending for relevant studies.
• Monitor conformance to Clinical Supplies Inventory Management with Interactive Response Technology (IRT) standards.
• Design, implement and Oversee return and destruction of IMPs from sites.
• Maintain external schedules at packaging contractors to meet production goals and communicate internal requirements to meet them (e.g. QA needs)
• Perform inventory checks and manage inventory levels and cycle count at the vendor yearly.
• Manage temperature excursions during transportation.
• BS in a scientific field, Pharmacy degree a plus.
• Minimum 5 - 10 years of relevant experience.
• Strong organizational, communication, and decision-making skills.
• Ability to effectively interact with all levels of internal and external management, including CROs.
• Self-motivated with the ability to work in an unstructured environment.
Please submit resume with job code MSC500 to Curis, Inc.
No phone calls, please.
Curis is an Equal Opportunity Employer
Curis is a publicly-traded biotechnology company (NASDAQ: CRIS) focused on the development and commercialization of innovative drug candidates for the treatment of human cancers.
Curis’s most advanced drug candidate is CUDC-907, an orally-available, small molecule inhibitor of histone deacetylase, or HDAC, and phosphatidylinositol-3-kinase, or PI3K enzymes. Curis is currently investigating CUDC-907 in a Phase 2 clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL with alterations in the MYC oncogene. Curis is also conducting a Phase 1 study of CUDC-907 in patients with solid tumors, and has recently directed efforts in this study to enroll patients with MYC oncogene involvement, including patients with NUT midline carcinomas, or NMC.
In addition, Curis is party to an exclusive collaboration agreement focused on immuno-oncology and selected precision oncology targets with Aurigene Discovery Technologies Limited, or Aurigene, a specialized, discovery stage biotechnology company and wholly-owned subsidiary of Dr. Reddy’s Laboratories (NYSE: RDY). In October 2015, Curis exercised options to license the first two programs under this collaboration. The first licensed program is focused on the development of orally-available small molecule antagonists of PD-1 and VISTA in the immuno-oncology field, including the development candidate currently being investigated in Phase I clinical trials, designated CA-170. The second licensed program is focused on orally-available small molecule inhibitors of Interleukin-1 receptor-associated kinase 4 (IRAK4) in the precision oncology field. In addition, in October 2015 the Company selected a second preclinical program within the immuno-oncology field that is focused on evaluating small molecule antagonists with dual PD-1 and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3) targeting properties. Curis expects to file an IND and initiate Phase 1 clinical testing of the IRAK4 inhibitor in 2016.
Curis’ other collaborators, F. Hoffmann-La Roche Ltd, or Roche, and Genentech Inc., or Genentech, a member of the Roche Group, are commercializing Erivedge® (vismodegib), a first-in-class orally-administered small molecule Hedgehog signaling pathway inhibitor, in advanced basal cell carcinoma, or BCC. Roche and Genentech are also continuing Erivedge’s clinical development in less severe forms of BCC, and have recently initiated clinical studies of Erivedge in idiopathic pulmonary fibrosis, or IPF, and myelofibrosis.
Our corporate culture is focused on learning and growing in a challenging environment with a committed group of peers working together as a team. For more information, visit Curis' website at www.curis.com.