Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that is generating T cells, in vivo, in high quantity that are fully functional whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Roche, Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University.
The Senior Clinical Supply Manager will be responsible for managing the investigational drug supplies for multiple products, which will require management of Clinical Supply Associate(s) and interaction with departments outside of Clinical Development and external Contract Manufacturing Organizations, in support of Inovio's Phase I-III programs. The Senior Clinical Supplies Manager will also participate in other activities needed to: 1) maintain Inovio's compliance with all local, regional, national, and international regulatory laws, standards, and regulations; and 2) ensure adherence to Inovio's Clinical Quality System.
Essential Job Functions:
Leads the coordination of activities to meet clinical supply needs, including comparator drugs, IMPD and QP release documents required for conduct of global clinical studies.
Reviews vendor proposals; review scope changes; review invoices for accuracy; forecast budget requirements.
Ensuring project timelines as well as cost and compliance requirements are met. Develop Request for Proposals (RFP's), collaborate with GBT Legal and Finance groups in reviewing and providing input of Master Services Agreements, contracts and other relevant documents.
Manage the activities required to meet clinical trial protocol requirements. This includes demand forecasting, distribution network planning, and IRT/IWRS issue identification and follow through on resolution, kit and label changes, and developing supply strategies to meet clinical plans while optimizing drug overage. Influences decisions in therapeutic areas from a clinical supply chain perspective.
Oversee global clinical drug supply activities associated with the team's trials (secondary packaging vendor selection, technical batch record review, QP Release coordination, clinical label design, packaging and labeling, IRT efficiencies).
Responsible for identifying, managing and providing necessary documents such as import licenses/permits needed for global clinical trials.
Manages the storage, distribution and tracking of the labeled and packaged inventory at the vendors/depots. Manage the multiple vendor relationships required to maintain the day-to-day fulfillment of drug shipment requests.
Manages the completion of investigations and CAPAs from excursions or deviations that may occur during shipment, handling or storage through collaboration with the applicable team members such as Quality, Clinical and applicable vendors.
Manages the returns/destruction and reconciliation of clinical product at the appropriate time in the study. Collaborates with Clinical Operations and the vendors to accomplish in a cost effective and compliant manner.
At least 3/6 years of clinical supplies management experience with bio-pharmaceutical products, including expertise in investigational drug supply management systems (e.g. IVRS).
Area(s) of expertise desired: biology, bioengineering, cell or molecular biology, cGMP compliance auditing, pharmaceutical manufacturing. Experience with vaccines highly preferred.
Excellent oral and written communication, interpersonal and organizational skills, and attention to detail.
Ability to interact effectively with management and prioritize multiple projects.
Technical proficiency, effective problem solving and critical thinking skills.
Ability to consistently meet tight timelines and deadlines.
Ability to work in a team environment.
A current US work authorization is required. For consideration, please send a brief cover letter describing your qualifications and a resume to firstname.lastname@example.org. For ease of processing, please type "BB Sr CS Manager" in the subject line.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.
Inovio Pharmaceuticals, Inc.