Operational Diagnostic Manager, Oncology Clinical Development

769 million. That’s how many lives our products touch. At Novartis, being there when and how it matters most for our patients and customers allows us to live our purpose and help bring maximum impact to health outcomes.<br><br>Furthering our commitment to transforming medicine for patients, Novartis is embarking on an ambitious and exciting journey to reinvent how we use technology, data and customer insights to better serve our consumer’s needs and put them on a path to better health. This includes taking bold approaches that begin with a customer-centric mindset and harness the power of today’s digital and data-driven healthcare revolution to continue to improve and extend even more people’s lives.<br><br>• Do you want to help people understand their disease and how to seek out the proper treatment for it?<br>• Do you want to support patients achieve the best possible outcomes?<br>• Do you want to deliver a leading customer experience at all touchpoints?<br>• Do you want to be at the forefront of leveraging today’s technology advances to create tomorrow’s healthcare innovations?<br><br>We believe the answers are found when curious, adventurous, and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to utilize the power of digital and data to individualize and maximize interactions with customers. Where you’re empowered to not fear failure when taking smart risks. And most importantly, where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.<br><br>As an <b>Operational Diagnostic Manager</b> you will provide operational and scientific support to the Global Biomarker and Diagnostic Teams (GBDTs) implementing protein- and nucleic acid-based testing solutions for clinical trials and diagnostic co-development efforts with particular focus on Immuno-Oncology (IO) portfolio programs. <br><br>You will provide hands-on planning and operational support and technology expertise to ensure smooth development and maintenance of accurate diagnostic program plans, budgets and documentation. Deliver project management expertise to support GBDT’s I/O portfolio to ensure day-to-day operational excellence during the execution of biomarker and diagnostic packages required for clinical trials and global therapeutic health authority approval, launch, and lifecycle management. <br><br><b>Your responsibilities will include:</b><br>• Support scientific and technical elements of GBDT objectives under the guidance of the Head of Diagnostic and Molecular Pathology to support I/O clinical development clinical programs.<br>• Facilitate diagnostic program team’s strategy in scenario planning with clearly defined decision point ensuring timely delivery of technical assessments for both protein- and nucleic acid-based testing systems.<br>• Working cross-functionally with technical and subject matter experts (SME), regulatory and clinical team members to ensure developed assays and/or diagnostic tests meet required criteria and specifications.<br>• Provide project management support for assigned GBDT and for Joint Program Teams (JPTs) established with external diagnostic development partners or vendors, as well as pharmaceutical companies in case of joint efforts and collaboration programs. Establishing and maintaining an accurate program plan (activities, timelines and resources) for the diagnostic program to enable execution according to the approved GBDT strategy.<br>• Request document lists and document downloads from the various document and data management systems to provide to interested parties during due diligence activities, incl. IO market assessment with up-to-date diagnostic tests and specific requirements with interpretation guidance. <br>• Prepare documents and data lists for review by the respective line functions / technical and operational experts.<br>• Responsible for developing meeting agendas and for preparing clear and accurate meeting minutes. <br>• Responsible for quality, accuracy, and maintenance of technical assessment files under the guidance of the Head of Program, Portfolio and Alliance Management (or delegate) using relevant Novartis systems and tools.<br><br>[#video#https://www.youtube.com/watch?v=ggbnzRY9z8w&feature=emb_logo{#400,300#}#/video#]