Master Data Management Lead for Cell and Gene Therapy
Orchestration and Exception Management (O&EM) is a new and fundamental capability for Technical Operations (PT) in order to deliver a future portfolio of Cell & Gene Therapy products. This portfolio of new products comes with the great promise to bring unprecedented medical advances to patients but also presents unique challenges: living products (e.g. cells) need to be delivered to patients in highly individualized supply chain models, which meet fast turn-around-times at a zero-error quality level.
Orchestration and Exceptions Management is one of three end-to-end value chain groups, responsible for the “virtual treatment journey” (data, transactions and documents). It is complementary to supply chain management that focuses on the “physical journey” (materials, specimens, product) and patient operations, responsible for the “patient journey”.
As the CGT Master Data Management Lead you will be shaping the future of CGT at Roche, by driving the MDM topic for CGT. You will be part of the O&EM team and will contribute to the evolution and growth of the capability from being able to support first late-stage clinical trial to being able to support a full portfolio of various CGT modalities in clinical and commercial stage. You will bring your passion and many skills to the table including the ability to bring structure to complex topics, focused and delivery oriented ways of working, visionary thinking and ability to translate visions to action.
Key Responsibilities & Job Requirements
The CGT Master Data Management Lead will…
Build and operationalize a master data management strategy for the CGT business unit (PTC), which is vital for successful management of “virtual” treatment journeys (data, transactions, documents)
Be responsible for translating the strategy into action to enable successful orchestration of Cell and Gene Therapies
Own the design of MDM functionality of two co-innovation solutions (Treatment Center Platform and a Treatment Management Platform) to ensure “first-time-right”, “capture at source”, compliant and fast data maintenance.
Define and align key MDM concepts, principles for CGT (e.g. data ownership, quality assurance, data governance, data maintenance) for areas where existing classical MDM practices come to a limit.
Build and lead a MDM expert team for CGT to address key challenges and to define, align and execute the CGT MDM strategy
Assess the current Roche/Genentech data landscape and practices in clinical and commercial that are relevant for our clinical stage, future commercial, CGT portfolio.
Identify potential synergies, gaps and risks for Cell & Gene Therapy clinical and commercial data management.
Build a robust and comprehensive mission, vision and strategy for (master) data management in Cell & Gene Therapy, considering O&EM, SAP ERP and other satellite applications, to enable the end-to-end value chain
As “MDM Product Owner”, define requirements for MDM system integrations particularly w.r.t key data objects like materials, customers and vendors- defining systems of record and points of integration.
Drive a data ownership culture that deeply anchors Master Data ownership in the business functions.
Define the operational Master Data set-up in collaboration with the CGT O&EM Operations Lead
Develop a CGT MDM stakeholder community to forster information exchange and alignment with the wider internal and external MDM community
Who You Are
Qualifications, Experience & Education
Diploma, master’s degree, or equivalent academic qualification ideally with focus on Supply Chain/ Value Chain Management, or Enterprise Information Management required
At least 10 years of work experience with extensive knowledge in Master Data Management in pharma, ideally several years in CGT
Experience related to virtual treatment journey” (Data, Transactions, Documents) in complex and large organization(s)
Proven track record of working with agile teams (e.g. SAFe, SCRUM, Design Thinking)
Experience working with SAP ERP (e.g. SAP ECC/S4HANA) and SAP MDM technology (e.g. SAP MDG), data quality tools (e.g., IDQ) and/or ETL tools
Knowledge and understanding of CGT MDM challenges and solution within clinical and commercial pharma;
Project experience in a key design role in designing, testing and rolling out MDM functionality for validated systems.
Good understanding of regulatory requirements related to data (e.g. GDPR, HIPAA, GxP Annex 11, CFR 21 part 11, specific regulations for ATMPs (e.g. around CoC/CoI)
Ability to navigate new innovation topics in large and complex organizations
Ability to define compelling strategies for business capabilities (such as MDM for CGT)
Outstanding collaboration skills
Ability to make strategic and tactical decisions based on limited and uncertain information in a complex and ever changing environment
Ability to see the connections between seemingly disparate MDM related issues (i.e. systems thinking), as well as distill complex and sometimes voluminous content into clear, concise, and engaging communications
Good communication and presentation skills, both written and verbal
Strong influencing and negotiation skills, including a record of accomplishment influencing without authority and driving cross-functional activities to successful conclusion
Ability to embed patient, customer and data focused ways of working in the team
Position requires up to 10% international travel.
Job Level:Manager with direct reports