Senior Manager, Supply Planning at Iovance Biotherapeutics in San Carlos

Job description

About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics , Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com . Amtagvi® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com . Overview The Senior Manager, Clinical Supply Planning designs, develops, and implements the clinical supplies strategy for clinical trials. This individual also manages activities including planning and forecasting of clinical supply, oversight of clinical packaging, labeling, and distribution operations at contracted manufacturing organizations (CMOs). Specific Responsibilities Oversee the Clinical labeling, packaging, release, distribution and returns of clinical supplies at external CMOs for the assigned studies, maintaining budget and ensuring that the projects are delivered on time. Create and manage Clinical forecast plans and budgets for clinical supplies for multiple programs and study levels, based on clinical study protocol and clinical operations plans. Create global supply strategies, supply plans to support Clinical studies; collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors to execute the strategies for the clinical studies. Support Clinical Operations with new site onboarding and the management, forecasting, and distribution of co-therapy drugs in the US and ex-US for all Clinical programs. Manage Clinical trial supply to ensure timely IMP production; manage inventory and worldwide distribution activities; ensure uninterrupted supply. Manage label development process from generation of the master label text to label printing. Implement scheduling software program for all clinical trials and future commercial requirements from collection to infusion incorporating chain of custody and identification, real time scheduling and tracking. Manage the development, review, and User Acceptance Testing (UAT) of the Interactive Response Technology (IRT) system. Review manuals and other documents with Clinical Operation team. Represent Supply Planning function at Clinical trial team meetings; communicate plans and timelines to internal and external customers and partners. Partner with other functional leaders in CMC, Regulatory Affairs, Clinical Operations and Quality Assurance in support of the study project teams and ensures timely supply for clinical trials. Deliver presentations and make recommendations to Senior Tech Ops, Clinical, and Commercial leadership. Other duties as assigned. Education and Qualifications Bachelor’s degree in a Biotech or related field. 9 years of experience with a BS degree, 7 years with a Masters in a related Clinical supply chain/planning/operations role. Prefer prior experience planning in time critical and temperature sensitive products. Ability to work with m